Title X Proposed Changes

Notice: This HHS-approved document is being submitted to the Office of the Federal Register (OFR) for publication and
has not yet been placed on public display or published in the Federal Register. The document may vary slightly from the
published document if minor editorial changes are made during the OFR review process. The document published in
the Federal Register is the official HHS-approved document.
Billing Code: 5140-34-P
Department of Health and Human Services
[Docket No.: HHS-OS-2018-0008]
42 CFR Part 59
RIN 0937-ZA00
Compliance with Statutory Program Integrity Requirements
AGENCY: Office of the Assistant Secretary for Health, Office of the Secretary, HHS.
ACTION: Proposed rule.
SUMMARY: The Office of Population Affairs (OPA), in the Office of the Assistant
Secretary for Health, proposes to revise its Title X regulations to ensure compliance with,
and enhance implementation of, the statutory requirement that none of the funds
appropriated for Title X may be used in programs where abortion is a method of family
planning and related statutory requirements. In addition, OPA proposes amendments to
the Title X regulations that would, among other things, clarify grantee responsibilities to
provide a broad range of family planning methods; to require documented compliance
with State and local laws requiring notification or the reporting of child abuse, child
molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking;
to provide free or low cost access to family planning services for those women who are
unable to obtain employer-sponsored insurance coverage for certain contraceptive
services due to their employers’ religious beliefs or moral convictions; to provide for the
appropriate expenditure of federal Title X funds on family planning services, rather than
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on lobbying or related activities; and to appropriately encourage family participation in
family planning decisions, all as required by Federal law.
DATES: Comments on this proposed rule are invited. To be considered, comments must
be received by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
ADDRESSES: Written comments may be submitted to the Department of Health and
Human Services, Office of the Assistant Secretary for Health, Office of Population
Affairs, as specified below. Any comment that is submitted will also be made available to
the public.
Warning: Do not include any personally identifiable information (such as name, address,
or other contact information) or confidential business information that you do not want
publicly disclosed. All comments may be posted on the Internet and can be retrieved by
most Internet search engines. No deletions, modifications, or redactions will be made to
the comments received. Comments may be submitted anonymously.
Comments, identified by “Family Planning” may be submitted by one of the following
methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions
for submitting comments.
Mail or Hand Delivery: Office of the Assistant Secretary for Health, Office of
Population Affairs, Attention: Family Planning, U.S. Department of Health and Human
Services, Hubert H. Humphrey Building, Room 716G, 200 Independence Avenue, SW,
Washington, D.C. 20201.
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Comments received will be posted without change to http://www.regulations.gov,
including any personal information provided.
FOR FURTHER INFORMATION CONTACT: Valerie Huber at (202) 690-7694.
SUPPLEMENTARY INFORMATION:
I. Background
A. Statutory Requirements of Title X of the Public Health Service Act and the Title
X Appropriations Acts
Title X of the Public Health Service Act (PHS Act or the Act), 42 U.S.C. 300
through 300a-6, was enacted in 1970 by Pub. L. 91-572. It authorizes the Secretary of
Health and Human Services, among other things, “to make grants to and enter into
contracts with public or nonprofit private entities to assist in the establishment and
operation of voluntary family planning projects which shall offer a broad range of
acceptable and effective family planning methods and services (including natural family
planning methods, infertility services, and services for adolescents).” PHS Act sec.
1001(a); 42 U.S.C. 300(a).
Presently, the Title X program funds approximately 90 public health departments
and community health, family planning, and other private nonprofit agencies through
grants, supporting delivery of family planning services at almost 4,000 service sites.1 As
a program designed to provide voluntary family planning services, the Title X program
should help men, women, and adolescents make healthy and fully informed decisions
about starting a family and determine the number and spacing of children.
1
Fowler, C. I., Gable, J., Wang, J., & Lasater, B. Family Planning Annual Report: 2016 National Summary
(Aug. 2017), https://www.hhs.gov/opa/sites/default/files/title-x-fpar-2016-national.pdf.
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Section 1008 of the Act contains the following prohibition, which has not been
altered since it was enacted in 1970:
None of the funds appropriated under this title shall be used in programs where
abortion is a method of family planning.
The Conference Report described the intent of this provision as follows:
It is, and has been, the intent of both Houses that funds authorized under this
legislation be used only to support preventive family planning services,
population research, infertility services and other related medical, information,
and educational activities. The conferees have adopted the language contained in
section 1008, which prohibits the use of such funds for abortion, in order to make
clear this intent.
H.R. Rep. No 91-1667, at 8-9 (1970) (Conf. Rep.). Later Congresses have, through
annual appropriations provisos, reiterated this requirement: “[A]mounts provided to said
[voluntary family planning] projects, under such title shall not be expended for
abortions.” See, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H,
Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations Act, 2017, Pub. L. 115-
31, Div. H, Title II, 131 Stat. 135, 521 (2017); Consolidated Appropriations Act, 2016,
Pub. L. 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015).
Since it originally created the Title X program in 1970, Congress has, from time
to time, imposed additional requirements on it. For example, the annual Title X
appropriation includes the provisos that “all pregnancy counseling shall be nondirective”2
2
See Omnibus Consolidated Rescissions and Appropriations Act, 1996, Pub. L. 104-134, Title II, 110
Stat.1321, 1321-221 (1996).
4
and that Title X funds “shall not be expended for any activity (including the publication
or distribution of literature) that in any way tends to promote public support or opposition
to any legislative proposal or candidate for public office.”3 See, e.g., Consolidated
Appropriations Act, 2018, Pub. L. 115-141, Div. H, Title II, 132 Stat. 348, 716-717
(2018); Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. H, Title II, 131
Stat. 135, 521 (2017).
Congress has given particular instructions for the services provided under Title X
to minors and other vulnerable populations. Congress specifically required that Title X
provide distinct services for adolescents. See PHS Act sec. 1001(a), 42 U.S.C. 300(a)
(requirement to provide “a broad range of acceptable and effective family planning
methods and services (including . . . services for adolescents)”). Congress also amended
Title X in 1981 to require that, “[t]o the extent practicable, entities which receive grants
or contracts under this subsection shall encourage familiy [sic] participation in projects
under this subsection.” Omnibus Budget Reconciliation Act of 1981, Pub. L. 97-35, sec.
931(b)(1), 95 Stat. 357, 570 (1981); PHS Act sec. 1001(a), 42 U.S.C. 300(a). Since
1997,4 Congress has included a rider in HHS’s annual appropriations act that provides
that “[n]one of the funds appropriated in this Act may be made available to any entity
under title X of the PHS Act unless the applicant for the award certifies to the Secretary
that it encourages family participation in the decision of minors to seek family planning
services.” Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 207, 132
3
See Omnibus Consolidated Rescissions and Appropriations Act, 1996, Pub. L. 104-134, Title II, 110
Stat.1321, 1321-221 (1996).
4
See Departments of Labor, Health and Human Services, and Education, and Related Agencies
Appropriations Act, 1998, Pub. L. 105-78, sec. 212, 111 Stat. 1467, 1495 (1997).
5
Stat. 348, 736 (2018). The same appropriations rider also requires that such an applicant
certify to the Secretary that it “provides counseling to minors on how to resist attempts to
coerce minors into engaging in sexual activities.” Id. By means of another rider, Congress
requires that, “[n]otwithstanding any other provision of law, no provider of services
under Title X of the PHS Act shall be exempt from any State law requiring notification or
the reporting of child abuse, child molestation, sexual abuse, rape, or incest.”
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 208, 132 Stat. 348,
736 (2018).
B. Title X Regulations
Since 1971, the Department has repeatedly exercised rulemaking authority with
respect to the Title X program. Section 1006(a) of the Act, 42 U.S.C. 300a-4, grants
rulemaking power to the Department: It provides that “[g]rants and contracts made under
this subchapter shall be made in accordance with such regulations as the Secretary may
promulgate.” The Department began to exercise that authority by issuing regulations
implementing section 1008 in 1971. See 36 FR 18465 (Sept. 15, 1971). Although those
regulations, and revised regulations issued in 1980 (45 FR 37436 (June 3, 1980)), as well
as guidelines promulgated in 1981, prohibited Title X projects from providing abortion as
a method of family planning, they did not provide further guidance on the application of
that prohibition. In 1982, the Department’s Office of Inspector General (OIG) audited 32
Title X clinics and found that the Department’s failure to provide such guidance had
created confusion about precisely what activities were proscribed by the section and
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resulted in variations in practice among grantees.5 The General Accounting Office (GAO,
now the Government Accountability Office) recommended that “the Secretary establish
clear operational guidance by incorporating into the Title X program regulations and
guidelines, HHS’ position on the scope of the abortion restriction in section 1008.”6
1. 1988 Regulations and Rust v. Sullivan
On February 2, 1988, the Secretary of Health and Human Services promulgated
Title X regulations (the “1988 Regulations”) to give specific program guidance regarding
the statutory prohibition on the use of Title X funds in programs where abortion is a
method of family planning. The Department noted “as a matter of experience with Title
X, its responsibility to administer the program as provided by Congress, and its general
administrative discretion, that the provisions of the current guidelines do not faithfully or
effectively maintain the prohibition contained in section 1008.” Statutory Prohibition on
Use of Appropriated Funds in Programs Where Abortion is a Method of Family
Planning; Standard of Compliance for Family Planning Services Projects, Final Rule, 53
FR 2922, 2923 (Feb. 2, 1988). The Department sought to address this deficiency.
The 1988 Regulations had several key features to support compliance with the
statutory prohibition. To more effectively implement section 1008, the regulations
prohibited Title X projects from counseling or referring project clients for abortion as a
method of family planning; required grantees to separate their Title X project—
physically and financially—from any abortion activities; and implemented compliance
5
HHS OIG, Review of PHS Title X Family Planning Grantees, Audit Control No. 12-33177 (Nov. 18,
1982).
6
GAO, No. HRD-82-106, Restrictions on Abortion and Lobbying Activities in Family Planning Programs
Need Clarification, at 22 (Sept. 24, 1982), https://www.gao.gov/assets/140/138760.pdf.
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standards for family planning projects under Title X to specifically prohibit certain
actions that promote or encourage, or advocate abortion as a method of family planning,
such as the use of project funds for lobbying for abortion, developing and disseminating
materials advocating abortion, or taking legal action to make abortion available as a
method of family planning. 53 FR 2922 (Feb. 2, 1988).
The 1988 Regulations were upheld on both statutory and constitutional grounds
by the United States Supreme Court in Rust v. Sullivan, 500 U.S. 173 (1991). The Court
first rejected the claim that the regulations violated the Administrative Procedure Act.
Under Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984),
the Supreme Court reasoned that “substantial deference” was owed “to the interpretation
of the authorizing statute by the agency authorized with administering it.” Rust, 500 U.S.
at 184. Applying that framework, the Court concluded that—although the language of
section 1008 did not speak directly to the issues of counseling, referral, advocacy, or
program integrity—because the “broad language of Title X plainly allows the Secretary’s
construction of the statute, . . . we are unable to say that the Secretary’s construction of
the prohibition in § 1008 to require a ban on counseling, referral, and advocacy within the
Title X project is impermissible.” Id. The Court similarly declined to view the regulations
skeptically because they represented a change in policy; instead, it noted that it “has
rejected the argument that an agency’s interpretation ‘is not entitled to deference because
it represents a sharp break with prior interpretation’ of the statute in question.” Id. at 186-
87. Accordingly, it reaffirmed that “[a]n agency is not required to ‘establish rules of
conduct to last forever,’ but rather ‘must be given ample latitude to ‘adapt [its] rules and
policies to the demands of changing circumstances.’” Id. (internal citations omitted).
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Finally, the Supreme Court concluded that the regulations’ “program integrity”
requirements—the portions of the regulations mandating separate facilities, personnel,
and records—were “based on a permissible construction of the statute and are not
inconsistent with congressional intent.” Id. at 188. On the contrary, the court noted, “if
one thing is clear from the legislative history, it is that Congress intended that Title X
funds be kept separate and distinct from abortion-related activities. . . . Certainly, the
Secretary’s interpretation of the statute that separate facilities are necessary, especially in
light of the express prohibition of § 1008, cannot be judged unreasonable.” Id. at 190.
Accordingly, the Court “defer[red] to the Secretary’s reasoned determination that the
program integrity requirements are necessary to implement the prohibition.” Id.
The Supreme Court similarly rejected constitutional challenges to the regulations.
As an initial matter, it upheld the statutory limitation of Title X funds to programs where
abortion is not a method of family planning, concluding that “[t]here is no question but
that the statutory prohibition contained in § 1008 is constitutional” because Congress
“may ‘make a value judgment favoring childbirth over abortion and . . . implement that
judgment by the allocation of public funds.’” Rust, 500 U.S. at 192 (internal citations
omitted; ellipsis in original). The Court explained that the counseling and referral
provisions were consistent with the First Amendment as follows:
The challenged regulations implement the statutory prohibition by prohibiting
counseling, referral, and the provision of information regarding abortion as a
method of family planning. They are designed to ensure that the limits of the
federal program are observed. The Title X program is designed not for prenatal
care, but to encourage family planning. A doctor who wished to offer prenatal
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care to a project patient who became pregnant could properly be prohibited from
doing so because such service is outside the scope of the federally funded
program. The regulations prohibiting abortion counseling and referral are of the
same ilk. . . . This is not a case of the Government ‘suppressing a dangerous idea,’
but of a prohibition on a project grantee or its employees from engaging in
activities outside of the project’s scope.
Rust, 500 U.S. at 193-94. The Court also explained that the requirement of physical and
financial program separation was consistent with the First Amendment as follows:
By requiring that the Title X grantee engage in abortion-related activity separately
from activity receiving federal funding, Congress has, consistent with our
teachings . . . not denied it the right to engage in abortion-related activities.
Congress has merely refused to fund such activities out of the public fisc, and the
Secretary has simply required a certain degree of separation from the Title X
project in order to ensure the integrity of the federally funded program.
Rust, 500 U.S. at 198. Finally, the Court held that the regulations did not violate any Fifth
Amendment rights because the “Government has no constitutional duty to subsidize an
activity merely because the activity is constitutionally protected and [Congress] may
validly choose to fund childbirth over abortion and ‘implement that judgment by the
allocation of public funds’ for medical services relating to childbirth but not to those
relating to abortion.” Id. at 201 (internal quotations omitted). The Court, thus, held that
the regulations “are a permissible construction of Title X and do not violate either the
First or Fifth Amendments to the Constitution.” Id. at 203.
2. Suspension of 1988 Regulations and Finalization of 2000 Regulations
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The 1988 Regulations continued to govern the Title X program until February 5,
1993, when a new Administration suspended them pursuant to a Presidential
Memorandum and issued a proposed regulation, 58 FR 7464, that it finalized seven years
later, see 65 FR 41270 (July 3, 2000) (the “2000 Regulations”). The 2000 Regulations
essentially returned to the 1981 Regulations (with one revision), which eliminated
provisions (a) prohibiting Title X projects from counseling or referring project clients for
abortion as a method of family planning; (b) requiring grantees to separate their Title X
project physically and financially from any abortion activities; and (c) implementing
compliance standards for family planning projects under Title X that specifically prohibit
certain actions designed broadly to promote or encourage abortion as a method of family
planning, such as the use of project funds to lobby for abortion, to develop and
disseminate materials advocating abortion, or to take legal action to make abortion
available as a method of family planning. While a contemporaneous notice stated that
more than separate bookkeeping entries and allocation of funds were necessary to
separate Title X project activities from non-Title X abortion activities, it discussed and
approved shared facilities, staff, and records, as long as costs were pro-rated and properly
allocated. See Provision of Abortion-Related Services in Family Planning Service
Projects, 65 FR 41281, 41282 (July 3, 2000). The 2000 Regulations also affirmatively
required that Title X providers counsel on, and refer for, abortion at the request of a Title
X client.
Finally, the 2000 Regulations “incorporated in the regulatory text the policies
relating to nondirective counseling and referral of the 1981 Program Guidelines for
Project Grants for Family Planning Services [1981 Guidelines].” 65 FR at 41271. Those
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1981 Guidelines, for the first time, required nondirective counseling about pregnancy
options, including abortion, and did so in a way that “creat[ed] the appearance of treating
each option identically,” despite the statutory prohibition on funding programs where
abortion is a method of family planning. See 53 FR at 2923 (discussing requirements
imposed by 1981 guidelines).
3. 2016 Regulation
On December 19, 2016, the Department finalized a rule that amended Title X
eligibility requirements, requiring that no grantee/recipient making subawards for the
provision of services as part of its Title X project prohibit an entity from receiving a
subaward for reasons other than its ability to provide Title X services. 81 FR 91852 (Dec.
19, 2016) (the “2016 Regulation”). The Department’s stated reason for issuing the rule
was to respond to new approaches to competing or distributing Title X funds that were
being employed by several states. To that end, the Department asserted that “[a]llowing
project recipients, including states and other entities, to impose restrictions on
subrecipients for reasons other than their ability to provide Title X services has been
shown to have an adverse effect on the number of people receiving Title X services and
the fundamental goals of the Title X program.”
Yet the 2016 Regulation, if implemented, would have entailed certain adverse
consequences. As an initial matter, it would have denied States and other grantees the
freedom to choose subrecipients as they saw fit, within the Title X statutory parameters.
Moreover, it could have resulted in the discontinuation of funding for entire States. A
comment from the chief legal officers and/or governors from nine States explained their
opposition to the rule as follows: “[The purpose of Title X is] to promote and assist in the
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establishment of voluntary family planning projects that offer a broad range of acceptable
and effective family planning methods and services. The program is also targeted toward
services for adolescents. This rule does not further that goal; but rather it is intended to
protect funding for certain providers even at the expense of the entire program.”
The 2016 Regulation took effect on January 18, 2017, but was nullified under the
Congressional Review Act less than three months later. The President signed Pub. L.
115-23, “Providing for congressional disapproval under chapter 8 of title 5, United States
Code, of the final rule submitted by Secretary of Health and Human Services relating to
compliance with Title X requirements by project recipients in selecting subrecipients” on
April 13, 2017. As a result, the 2016 Regulation must be “treated as though such rule had
never taken effect.” 5 U.S.C. 801(f). Because of the joint resolution of disapproval, the
Department is prohibited from reissuing the nullified 2016 Regulation in “substantially
the same form” or issuing a “new rule that is substantially the same” as the nullified 2016
Regulation. 5 U.S.C. 801(b).
II. Need for Change
The Department must consider the effectiveness of its policies enforcing statutory
mandates on a continuing basis. As the Supreme Court noted in Rust v. Sullivan, an
agency is not required to establish rules of conduct to last forever, but rather must be
given ample latitude to adapt its rules and policies to the demands of changing
circumstances. 500 U.S. 173, 186-87 (1991). “Agencies are free to change their existing
policies as long as they provide a reasoned explanation for the change.” Encino
Motorcars, LLC v. Navarro, 136 S. Ct. 2117, 2125 (2016). This “reasoned analysis”
requirement does not demand that an agency “demonstrate to a court’s satisfaction that
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the reasons for the new policy are better than the reasons for the old one; it suffices that
the new policy is permissible under the statute, that there are good reasons for it, and that
the agency believes it to be better, which the conscious change of course adequately
indicates.” U.S. Aid Funds, Inc. v. King, 200 F. Supp. 3d 163, 169–70 (D.D.C. 2016)
(citing FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009)); see also New
Edge Network, Inc. v. FCC, 461 F.3d 1105, 1112–13 (9th Cir. 2006) (rejecting an
argument that “an agency changing its course by rescinding a rule is obligated to supply a
reasoned analysis for the change beyond that which may be required when an agency
does not act in the first instance”).
The Department now believes the policies outlined in this proposed rule are based
on the best interpretation of, and provide appropriate guidance for compliance with, Title
X. In particular, the Department believes that the policies outlined in this proposed rule
provide for the best interpretation of section 1008 of Title X and of associated provisions,
including the appropriations provisos and riders governing the Title X program. The
standards proposed here are designed to refocus the Title X program on its statutory
mission—the provision of voluntary, preventive family planning services specifically
designed to enable individuals to determine the number and spacing of their children—
while clarifying that pregnant women must be referred for appropriate prenatal care
services, rather than receiving them within a Title X project, because those services are
not part of family planning services within the Title X program. See H.R. Rep. No. 91-
1472 (1970), as reprinted in 3 U.S. Code Cong. & Adm. News 5068 (discussing the scope
of the program).
A. Statutory Compliance
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As discussed in section II.B. below, the Department interprets section 1008 to
establish a broad prohibition on funding, directly or indirectly, activities related to
abortion as a method of family planning. Thus, the Department believes that section
1008’s mandate is most clearly met where there is a clear separation between Title X
programs and programs in which abortion is presented or provided as a method of family
planning. The 2000 regulations are inconsistent with that interpretation insofar as they
require referral for abortion, allow the use of funds for infrastructure building that could
be used for abortion services, and do not require clear physical and financial separation
between Title X activities and abortion-related services. In addition, the regulations do
not ensure transparency and accountability in the use of taxpayer funds insofar as they
fail to provide the Department information about subrecipients, to ensure monitoring for
potential misuse of funds, and to address expressly federal laws (including a Title X
specific appropriations proviso) that prohibit the use of taxpayer funds for political
activity or lobbying. Finally, the regulations prescribe inadequate grant criteria for
selecting recipients of Title X funds who will comply with all of these requirements. If
finalized and implemented as proposed, the new regulations would contribute to more
clients being served, gaps in service being closed, and improved client care that better
focuses on the family planning mission of the Title X program.
B. Ensuring That Title X Funds Are Not Used in Projects Where Abortion Is a
Method of Family Planning
As part of its ongoing obligation to ensure compliance with federal law, the
Department has determined that the existing regulations do not ensure compliance with
the prohibition in section 1008 that “none of the funds appropriated” for Title X “be used
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in programs where abortion is a method of family planning.” In the view of the
Department, that prohibition includes any action that directly or indirectly facilitates,
encourages, or supports in any way the use of abortion as a method of family planning.
That interpretation follows from the text and purpose of the statute.
To begin, section 1008 “broad[ly]” “prohibits the use of Title X funds ‘in
programs where abortion is a method of family planning.’” Rust, 500 U.S. at 184.
Although Title X does not define “method of family planning,” the ordinary meaning of
that phrase, coupled with the statutory examples of “natural family planning methods”
and “infertility services,” 42 U.S.C. § 300(a), suggests decisions about the number and
spacing of one’s children. This interpretation is consistent with the Title X regulation’s
description of the purpose of the program. See 42 CFR § 59.1 (Title X voluntary family
planning “projects shall consist of the educational, comprehensive medical, and social
services necessary to aid individuals to determine freely the number and spacing of their
children.”). And the exclusion of funding for abortion as a method for such decisions
“embodies a view that abortion is inappropriate as a method of family planning.” 53 FR
2922, 2922 (Feb. 2, 1988). Congress, thus, chose to fund Title X programs/projects that
offer only preconception methods of family planning and “create[d] a wall of separation
between” those programs and others where abortion is “a method of family planning.” 53
FR at 2922. The text of Title X’s prohibition is also notably broad in prohibiting funding
not only for providing and promoting abortion itself as a method of family planning, but
in prohibiting funding for any program “where abortion is a method of family
planning”—even if funds spent on such a program could be insulated from the provision
or promotion of abortion.
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The legislative history confirms this meaning. The Conference Report stated that
“[i]t is, and has been, the intent of both Houses that the funds authorized under this
legislation be used only to support preventive family planning services, population
research, infertility services, and other related medical, information and education
activities.” H.R. Conf. Rep. No. 91–1667 at 8 (1970). Congressman John D. Dingell, Jr.,
the principal sponsor of section 1008, further explained on the floor of the House:
I set forth in my extended remarks the reasons why I offered to the amendment
[sic], which prohibited abortion as a method of family planning…. With the
“prohibition of abortion”, the committee members clearly intended that abortion
is not to be encouraged or promoted in any way through this legislation. Programs
that include abortion as a method of family planning are not eligible for funds
allocated through this Act.
116 Cong. Rec. 37375 (1970).
To give effect to Section 1008, the Department now considers it important and
appropriate to draw a wall of separation between Title X programs and prohibited
activities. Title X programs may not directly or indirectly facilitate, promote, or
encourage abortion in any way. For example, referral is an integral part of the provision
of any method of family planning. When provided for abortion, a referral necessarily
treats abortion as a method of family planning and runs afoul of the statute. Similarly,
Title X programs that subsidize other programs where abortion is a method of family
planning, through infrastructure building, cost sharing, or otherwise, run afoul of the
statute. Congress made clear that “none” of the Title X funds should go to support such
programs.
17
The Department previously took the position, in a notice published concurrently
with the 2000 Regulations, that section 1008 precluded only funding of activities that
“directly facilitate the use of abortion as a method of family planning, such as providing
transportation for an abortion, explaining and obtaining signed abortion consent forms
from clients interested in abortions, negotiating a reduction in fees for an abortion, and
scheduling or arranging for the performance of an abortion, promoting or advocating
abortion within Title X program activities, or failing to preserve sufficient separation
between Title X program activities and abortion-related activities.” Provision of
Abortion-Related Services in Family Planning Services Projects, 65 FR 41281 (July 3,
2000) (“Notice”). The Department mandated that providers provide counseling on and
referral for abortion, if requested by the client.
But the Department no longer considers that position appropriate in light of
restrictions set forth in the statute. Section 1008 does not merely prohibit “direct” funding
for abortion. It prohibits all funding for programs “where abortion is a method of family
planning.” That broad language captures not just the activities of the program itself, but
also any activities facilitated, encouraged, or promoted by the program. Limiting section
1008’s prohibition to only “direct” facilitation of abortion creates confusion about which
activities are proscribed by the section, and, in the Department’s view, fails to ensure that
Title X funds are not being used in “programs where abortion is a method of family
planning.” The Department’s previous view was erroneous in requiring counseling and
referral for abortion, allowing the sharing of physical space, and permitting infrastructure
building when physical space could be shared. In these proposed regulations, the
Department proposes to correct all three errors.
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1. Abortion Counseling and Referral Requirement.
As discussed above, the Department has concluded the requirement under 42 CFR
§ 59.5(a)(5) that a project must provide abortion counseling and referrals to pregnant
women upon request is inconsistent with section 1008.7 That requirement appears to be
premised on the notion that the statute is neutral on the question whether Title X funds
may be used to encourage or promote abortion. But the Department rejects that notion:
“Family planning,” as clearly manifested by the text of Title X and bolstered by its
legislative history, refers to activities with the purpose of facilitating the initiation of, or
preventing, pregnancy, not terminating it.8 Understood in context, referral activities are
integral parts of the provision of any method of family planning. Thus, Section 1008
prohibits a Title X grantee, within the scope of the Title X project, from referring for
abortion as a method of family planning. In the 2000 regulation, the Department took the
position that the statute’s requirement that pregnancy counseling be nondirective justified
imposing a regulatory requirement of abortion referral upon request. The Department
now believes this view was erroneous. Referrals for abortion are, by definition, directive.
Therefore, such referral activity is inconsistent with the prohibition on abortion as a
method of family planning in Section 1008.
7
As described in the preamble to the 1988 Regulations, 53 FR at 2923, prior to issuance of any regulations
pursuant to Title X, the Department had, since 1972, interpreted section 1008 not only as prohibiting the
provision of abortion but also as prohibiting Title X projects from in any way promoting or encouraging
abortion as a method of family planning. Further, based on the legislative history, the Department had also,
since 1972, interpreted section 1008 as requiring that the Title X program be "separate and distinct" from
any abortion activities of a grantee. However, in such interpretations, the Department generally took the
view that activity that did not have the immediate effect of promoting abortion, or which did not have the
principal purpose or effect of promoting abortion, was permitted. Id.
8
Put differently, the family planning services covered by Title X are almost exclusively preconception
services, while abortion is not.
19
In addition, the requirement that Title X projects offer pregnant women the
opportunity to be provided information and counseling regarding, and referrals for,
abortion is inconsistent with the conscience protections embodied in the Church, Coats-
Snowe, and Weldon Amendments. See 42 U.S.C. 300a-7; PHS Act sec. 245, 42 U.S.C.
238n; Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 507(d), 132
Stat. 348, 764 (2018); Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div.
507(d), 131 Stat. 135, 562 (2017). The Department acknowledged this problem in the
preamble to 2008 regulations implementing these conscience protections. Ensuring that
Department of Health and Human Services Funds Do Not Support Coercive or
Discriminatory Policies or Practices in Violation of Federal Law; Final Rule, 73 FR
78072 (Dec. 19, 2008). Responding to commenters who suggested that enforcing the
conscience statutes would be inconsistent with the abortion referral requirements for
family planning clinics in the Title X regulations, the Department observed, “[w]ith
regards to the Title X program, Commenters are correct that the current regulatory
requirement that grantees must provide counseling and referrals for abortion upon request
(42 CFR § 59.5(a)(5)) is inconsistent with the health care provider conscience protection
statutory provisions and this regulation. The Office of Population Affairs, which
administers the Title X program, is aware of this conflict with the statutory requirements
and, as such, would not enforce this Title X regulatory requirement on objecting grantees
or applicants.” 73 FR at 78087.9 Although those 2008 conscience statute regulations were
partially repealed in 2011, 76 FR 9968 (February 23, 2011), the underlying statutes
9
In January 2018, the Department issued a notice of proposed rulemaking to revise and expand these
regulations. See Protecting Statutory Conscience Rights in Health Care; Delegation of Authority, 83 FR
3880 (Jan. 26, 2018).
20
remain valid and in place, and the reasoning in the preamble to the 2008 regulations on
this point remains persuasive. The abortion referral and counseling requirements in the
current Title X regulations, thus, cannot be enforced against objecting grantees or
applicants, and such requirements cannot be used to deny participation in the Title X
program or a Title X project of objecting family planning providers.10
For these reasons, the Department proposes to change the Title X regulations to
eliminate the requirement that Title X projects provide abortion referral and counseling.
In addition, consistent with the purpose of the program, the proposed rule would prohibit
recipients from using Title X funds to perform, promote, refer for, or support abortion as
a method of family planning. This rule would better align with both the best reading of
section 1008 and with the Federal conscience statutes. Recognizing, however, the duty of
a physician to promote patient safety, a doctor would be permitted to provide
nondirective counseling on abortion.11 Such nondirective counseling would not be
considered encouragement, promotion, or advocacy of abortion as a method of family
planning, as prohibited under section 59.16 of this proposed rule. Moreover, as permitted
by the 1988 Regulations, a doctor would be permitted to provide a list of licensed,
qualified, comprehensive health service providers, some (but not all) of which provide
abortion in addition to comprehensive prenatal care. Providing such a list would be
10
We note that the Department has recently received a letter from the Attorney General of the State of
Texas alleging discrimination against the State of Texas with respect to Title X, contending that the
Department had improperly removed Texas from the list of eligible Title X grant recipients and referencing
the protections embodied in the Church, Hyde/Weldon, and Coats/Snowe Amendments. Attorney General
of Texas, Letter on Discrimination Against Texas Regarding Title X Grants (March 22, 2018),
.https://www.texasattorneygeneral.gov/files/epress/Texas_AG_letter_to_HHS_regarding_Title_X.pdf?cach
ebuster:96.
11
That counseling on abortion be nondirective is required by the appropriations law applicable to Title X.
See Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, Title II, 132 Stat. at 716-17 (“all
pregnancy counseling shall be nondirective”).
21
permitted only if a woman who is currently pregnant clearly states that she has already
decided to have an abortion. This is discussed in more detail below, and the Department
seeks public comment on this issue.
2. Possible Co-Mingling of Funds Between Title X Projects and the Abortion

Activities of the Title X Grantee/Subrecipient
A second statutory problem is raised by the fact that the 2000 Regulations
required financial, but not physical, separation between Title X Projects and the abortion
activities of the Title X grantee/subrecipient. Organizations that actively include abortion
as a method of family planning have consistently received Title X funding. The 2000
regulations permit shared facilities, common staff, and single file systems between Title
X supported activities and non-Title X abortion-related activities in the following ways:
(a) A common waiting room is permissible, as long as the costs [are] properly pro-
rated; (b) common staff is permissible, so long as salaries are properly allocated
and all abortion related activities of the staff members are performed in a program
which is entirely separate from the Title X project; (c) a hospital offering abortions
for family planning purposes and also housing a Title X project is permissible, as
long as the abortion activities are sufficiently separate from the Title X project; and
(d) maintenance of a single file system for abortion and family planning patients is
permissible, so long as costs are properly allocated. 65 FR 41281, 41282 (July 3,
2000).
These shared facilities create a risk of the intentional or unintentional use of Title X funds
for impermissible purposes, the co-mingling of Title X funds, and the appearance and
perception that Title X funds being used in a given program may also be supporting that
22
program’s abortion activities. Even with the strictest accounting and charging of
expenses, a shared facility greatly increases the risk of confusion and the likelihood that a
violation of the Title X prohibition will occur.
This concern is particularly acute in light of more recent evidence that abortions
are increasingly performed at sites that focus primarily on contraceptive and family
planning services—sites that could themselves be recipients of Title X funds. The
Guttmacher Institute’s recent report, Abortion Incidence and Service Availability in the
United States, 2014, provides detail about the various types of facilities at which
abortions are performed. It notes that “nonspecialized clinics”—i.e., “nonhospital sites in
which fewer than half of patient visits are for abortion services,” including physicians’
offices—may provide 400 or more abortions per site per year. The report notes that,
“[w]hile many of these [nonspecialized] clinics primarily serve contraceptive and family
planning clients, about half provided 400 or more abortions per year.” It defines
“abortion clinics” as “nonhospital facilities in which half or more of patient visits are for
abortion services, regardless of annual abortion caseload.” According to the Guttmacher
Institute, nonspecialized clinics accounted for 24% of all abortions in 2008;12 31% in
2011;13 and 36% in 2014.14 In addition, nonspecialized clinics represented 26% of
abortion providers in 2008; 30% in 2011; and 31% in 2014. Further, despite a 3% drop in
12
Jones, R.K., Kooistra, K., Abortion incidence and access to services in the United States, 2008,
Guttmacher Institute Perspectives on Sexual and Reproductive Health (Jan. 10, 2011),
https://www.guttmacher.org/sites/default/files/article_files/4304111.pdf.
13
Jones, R.K., Jerman, J., Abortion incidence and service availability in the United States, 2011,
Guttmacher Institute Perspectives on Sexual and Reproductive Health (Feb. 3, 2014),
https://www.guttmacher.org/sites/default/files/article_files/abortion_incidence_in_the_united_states_2011.
pdf.
14
Jones, R.K., Jerman, J., Abortion incidence and service availability in the United States, 2014,
Guttmacher Institute Perspectives on Sexual and Reproductive Health (Jan. 17, 2017),
https://www.guttmacher.org/sites/default/files/article_files/abortion-incidence-us.pdf.
23
the total number of abortion facilities between 2011 and 2014, the number of abortion
clinics dropped by 17%, while the number of nonspecialized clinics performing abortions
remained stable. The performance of abortions at nonspecialized clinics that also may
provide Title X services increases the risk and potential both for confusion and for the co-
mingling or misuse of Title X funds.
Together, these circumstances create a risk of intentional or unintentional misuse
of Title X funds and have created public confusion over the scope of Title X services,
whether Title X projects provide abortion services, and whether the Federal government
(and, ultimately, Federal taxpayers), is funding abortion services provided by
organizations that are recipients (or subrecipients) of Title X grants/funds. The
Department believes that such potential co-mingling and confusion is evidence that the
2000 Regulations neither adequately reflect nor further the text and purpose of section
1008. As discussed above, the Department interprets section 1008 to require Title X
project activities to be separate and distinct from non-Title X abortion activities. Thus,
when a grantee conducts abortion activities that are not part of the Title X project, and
would not be permissible if they were, the grantee must ensure that the Title X-supported
project is separate and distinguishable from those other activities.
The proposed regulation would reduce, and potentially eliminate, any
confusion—actual or potential—as to the scope of services supported by Title X funds by
requiring Title X projects to maintain clear physical and financial program separation
from programs that use abortion as a method of family planning. This bright-line rule
would create a clearer, more transparent system of separation and accountability, similar
to that established by the 1988 Regulations and affirmed by the Supreme Court in Rust. It
24
would also assure fidelity to the text and purpose of section 1008, and facilitate auditing
and enforcement of program requirements. The proposed rule would not, however,
restrict the use of non-Title X funds outside the Title X program, nor would it impose
restrictions on funds provided by other Federal programs. And it would not prevent a
woman from seeking and obtaining an abortion. It would only draw a bright line between
permissible services provided with Title X funds and services that cannot be so provided.
3. Infrastructure Building that Creates Fungibility Concerns Related to

Abortion Services.
The current flexibility in the use of Title X funds raises additional concerns about
the fungibility of assets that could be used—sometimes with an attendant increase in
marginal cost—to build infrastructure for abortion services. By law, Title X providers
must secure other sources of revenue to leverage Title X grants. See 42 CFR § 59.7(c)
(“No grant may be made for an amount equal to 100 percent for the project’s estimated
costs.”). Medicaid is the primary source of additional revenue. But unlike Title X, which
is a grant program, Medicaid is a reimbursement program. By their very nature, grants
afford considerably greater latitude and versatility to grantees on how funds are used. If
an organization receives both Medicaid and Title X funding, for example, Medicaid
reimbursement payments might be used to cover many family planning services, freeing
up Title X funds to be used for infrastructure-building and support. In its Moving
Forward: Family Planning in the Era of Health Reform report, the Guttmacher Institute
reported that providers do in fact use Title X funds in this way:
Up-front funding helps supply a cash-flow cushion for providers who are often
operating on tight and uncertain budgets. More specifically, Title X recipients use
25
the program’s flexible grant funding in a variety of ways to address staff-related
issues, including hiring individuals capable of meeting communities’ need for
linguistic or culturally appropriate care, training staff on the latest medical
techniques or to provide tailored counseling for clients with special needs,
maintaining sufficient staff to operate outside regular business hours and paying
sufficient wages to staff at all levels to reduce high turnover rates that often
plague health centers. Providers may also use Title X funds for operational
investments, such as utilizing advanced technologies and facilitating more
accessible and efficient client care…. Finally, Title X undergirds the
infrastructure and general operations of the health centers themselves in ways that
Medicaid and private insurance simply cannot. Title X funds go to centers up
front as grants, rather than after the fact as reimbursement for services centers
have provided to individual enrollees. Providers have long relied on that
flexibility to hire, train and maintain their staff to meet the diverse needs of their
clients and community. They have also depended on these grants to keep their
lights on and their doors open, to adapt to unexpected budget shortfalls and to
make improvements to their facilities. Such versatility is even more vital in the
era of health reform. The up-front investments in staffing, training and
infrastructure needed to work effectively with health plans—and to thereby draw
in new revenue to serve more clients—are substantial, and flexible funds like
those provided through Title X are ideal for such investments. Those expenses
include upgrading health information technology systems and training staff on
their use, training clinicians and front-line staff to properly code and bill for
26
services provided, obtaining the appropriate credentials to ensure third-party
reimbursement, and devoting time and resources to researching available health
plans and negotiating contracts with them. They may also include expenses
related to outsourcing some administrative functions to private contractors or as
part of collaborations with other health care providers.15
In another report, Guttmacher expanded upon the infrastructure support afforded by Title
X funding:
Title X can subsidize the intensive outreach necessary to encourage some
individuals to seek services. Furthermore, by paying for everything from staff
salaries to utility bills to medical supplies, Title X funds provide the essential
infrastructure support that enables clinics to go on and claim Medicaid
reimbursement for the clients they serve.16
Infrastructure building may include securing physical space, developing or
acquiring health information technology systems (including electronic health records),
bulk purchasing of contraceptives or other clinic supplies, clinical training for staff, and
community outreach and recruiting. An anecdotal story from Guttmacher in the report
Stronger Together: Medicaid, Title X Bring Different Strengths to Family Planning Effort
reinforces the point:
15
Sonfield, A., Hasstedt, K., Gold, R. B., Moving forward. Family planning in the era of health reform,
Guttmacher Institute (March 2014), https://www.guttmacher.org/report/moving-forward-family-planning-
era-health-reform.
16
Gold, R. B., Stronger Together: Medicaid, Title X Bring Different Strengths to Family Planning Effort,
Guttmacher Institute (May 17, 2007), https://www.guttmacher.org/gpr/2007/05/stronger-together-
medicaid-title-x-bring-different-strengths-family-planning-effort.
27
Ibarra of California’s Venice clinic says her agency sends street outreach teams
into the community with backpacks of condoms and basic educational materials,
while other teams make regular visits to homeless shelters. Often, it will take
multiple visits to a shelter or street-corner conversations until someone feels safe
enough to come to a clinic. According to Ibarra, Title X will fund and train the
outreach workers, purchase the condoms and often even develop the educational
materials they distribute. Only when a client actually comes to the clinic is
reimbursement available (through Medicaid or any other source), and then only if
the client qualifies. According to Annette Amey, director of program evaluation
for CFHC, “it’s all about getting people to the inside of the clinic door, and for
that Title X dollars are indispensable.”
The Department is concerned about this infrastructure building on both statutory
and policy grounds. As a statutory matter, the use of Title X funds to build infrastructure
that can be used for purposes prohibited with these funds, such as support for the abortion
business of a Title X grantee or subrecipient, clearly violates section 1008. As a policy
matter, Title X is the only discrete, domestic, Federal grant program focused solely on the
provision of cost-effective family planning methods and services. As the number of
Americans at or below the poverty level has increased, the need to prioritize the use of
Title X funds for the provision of family planning service has as well.
The proposed physical and financial separation of Title X projects from all
activities that could not be funded by those programs, as well as the separate provision
addressing the use of Title X funds for infrastructure purposes, would address this
concern. Because Title X projects would not share any infrastructure with abortion-
28
related activities, direction of Title X funds toward such infrastructure would no longer
threaten to divert funds to impermissible activities. That separation would thus ensure
that Title X funds are used for the purposes expressly mandated by Congress, that is, to
offer family planning methods and services—and that any infrastructure built with Title
X funds would not be used for impermissible purposes.
C. Ensuring Responsible Use of Taxpayer Funds.
In addition to ensuring compliance with section 1008, the Department seeks to
address three additional concerns posed by the 2000 regulations with respect to the
responsible use of taxpayer funds.
1. Ensuring Transparency of Subrecipients of Funds to Assist Oversight and

Enforcement Efforts.
Transparency in the use of governmental funds is an important principle for
responsible government. This transparency helps to ensure accountability for, and wise
use of, taxpayers’ money. Current Title X regulations, however, do not require grantees
to submit information to the government about their subrecipients, referral agencies, or
other partners to whom Title X funds may flow. This lack of information is a barrier to
OPA’s oversight of the activities of its program and project subrecipients and, ultimately,
to governmental accountability for those funds.
Therefore, under the new regulations, Title X grant applicants would be required
to share the following within their applications and, if funded, in required reports and
responses to performance measures, wherever practicable:
 Names and locations of subrecipients, referral individuals and agencies, as well as
services provided and to be provided by those entities;
29
 Detailed descriptions of any partnerships, including the extent of collaboration,
with subrecipients, referral individuals and agencies, as well as less formal
partners within the community, in order to demonstrate a seamless continuum of
care for clients;
 A clear explanation of how the grantee will ensure adequate oversight and
accountability for quality and effectiveness outcomes among subrecipients and
those who serve as referrals for ancillary or core services.
2. Expanding Monitoring of the Use of Title X funds.
The Department has additional concerns about the potential for misuse of Title X
funds and misbilling or overbilling of other Federal or state programs by Title X grantees
under the current regulatory scheme. Although Title X is the only discrete domestic
family planning grant program, other programs also fund family planning. In fact, 75% of
all family planning services are funded through Medicaid; only 10% are funded through
Title X.17 Not infrequently, Title X grant recipients also claim Medicaid reimbursement
for services they provide to clients. In fact, according to the National Family Planning &
Reproductive Health Association, “Medicaid is by far the largest revenue stream for the
Title X provider network, comprising 40% of an average funding mix [and] is also the
fastest growing revenue stream.”18 It is not inconsequential, then, to note cases of
misuse/overbilling with respect to reimbursement for family planning services.
17
Hasstedt, K., Sonfield, A., Gold, R.B. Public funding for family planning and abortion services, FY
1980-2015, Guttmacher Institute (April 2017), https://www.guttmacher.org/report/public-funding-family-
planning-abortion-services-fy-1980-2015.
18
Hays B., Title X in Context, National Family Planning & Reproductive Health Association (July 2016),
https://www.nationalfamilyplanning.org/file/documents---policy-briefs/Title-X-in-Context.pdf.
30
Numerous studies have documented misuse/overbilling for family planning
services. The HHS Office of Inspector General (OIG) conducted a Federal audit of
Medicaid-reimbursed claims for family planning services in New York State and found
that about 25% of a sample of such claims were not eligible for Family Planning Benefit
Program (FPBP) reimbursements.19 Overall, 61 Federal audits conducted by the
Department’s OIG found overbilling among Medicaid providers. On average, at least
14% of the Federal share of funding was overbilled by providers, with one provider
overbilling at least 54% of the Federal share.20 Although misuse among Medicaid
recipients does not necessarily predict or imply misuse of grant funds among Title X
grantees, the Department is aware of specific examples of misuse/overbilling by such
grantees. For example:
 In New York State, one Medicaid provider was found to have received significant
overpayments for family planning services.21 The same provider, also a Title X
grantee,22 was found by the Health Resources and Services Administration
(HRSA) to be in billing violation during a program integrity audit.23
19
HHS OIG, Review of Federal Medicaid Claims Made for Beneficiaries in the Family Planning Benefit
Program in New York State, Report No. A-02-07-01001 (May 22, 2008),
https://oig.hhs.gov/oas/reports/region2/20701001.htm.
20
Foster, C.G. , Profit. No Matter What, 2017 Report on Publicly Available Audits of Planned Parenthood
Affiliates and State Family Planning Programs, Charlotte Lozier Institute Special Report Series 3 (Jan. 4,
2017), https://lozierinstitute.org/profit-no-matter-what.
21
Letter, State of New York Office of the Medicaid Inspector General, “Letter on Family Planning
Chargeback to Managed Care Network Providers, Final Report, Audit # 09-1415, Provider # ---,” --- (June
10, 2009).
22
Philipson, D. , Letter to the editor: Title X initiative threatens to affect the well-being of our
communities, The Rivertowns Enterprise (Apr. 1, 2011), https://www.plannedparenthood.org/planned-
parenthood-hudson-peconic/newsroom/letter-editor-title-x-initiative-threatens-affect-well-being-our-
communities-rivertowns-enterpr.
23
HRSA, Program Integrity: FY13 audit results (2017),
https://www.hrsa.gov/opa/programintegrity/auditresults/fy13results.html.
31
 A Medicaid provider, under threat of being terminated from the Illinois Medicaid
program, was charged with overbilling for birth control.24 This same provider is a
current Title X grant recipient.25
 Another Title X recipient and Medicaid provider in Pennsylvania was found out
of compliance by HRSA for overbilling.26
 A Medicaid provider (and Title X grantee) in Washington State was audited
following charges that it engaged in improper billing practices. The Washington
Medicaid Fraud Control Unit investigated; as a result of the investigation, the
grantee reimbursed the Medicaid program.27
 The state of Nebraska found that significant abortion-related expenses were
charged against the Title X grant by a subrecipient.28 The same subrecipient, also
a Medicaid provider, was also charged with “false, fraudulent, and/or ineligible
claims for reimbursement” to Medicaid.29 In addition, a sample of 10 payments to
24
Wang, A., Planned Parenthood Settles with Illinois on Medicaid Payments, Modern Healthcare (Sept. 6,
2012), http://www.modernhealthcare.com/article/20120906/INFO/309069993; Wang, A., Medicaid Probes
Planned Parenthood Fees, Crain’s Chicago Business (July 9, 2012),
http://www.chicagobusiness.com/article/20120707/ISSUE01/307079977/medicaid-probes-planned-
parenthood-of-illinois.
25
Wang, A.L., Planned Parenthood settles with Illinois on Medicaid payments, Modern Healthcare (Sept.
6, 2012) http://www.modernhealthcare.com/article/20120906/INFO/309069993; HHS Office of Population
Affairs, Title X family planning directory of grantees (2017), https://www.hhs.gov/opa/title-x-family-
planning/title-x-grantees/index.html.
26
HRSA, Program Integrity: FY2012 audit results (2017),
https://www.hrsa.gov/opa/programintegrity/auditresults/fy12results.html.
27
Stucke, J., Planned Parenthood undergoes leadership changes, audit, The Spokesman-Review (May 21,
2009), http://www.spokesman.com/stories/2009/may/21/planned-parenthood-undergoes-leadership-
changes/. Referenced Audit # 09-04-08 of Yakima County, Washington.
28
Nebraska Auditor of Public Accounts, State of Nebraska Statewide single audit: Year ended June 20,
2015 (2016), http://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-
July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.
29
Second Amended Complaint, Thayer v. Planned Parenthood of the Heartland, No. 4:11-cv-00129 (S.D.
Iowa, filed July 26, 2012).
32
subrecipients was reviewed by the state of Nebraska; nine of the ten lacked
documentation to support Title X reimbursement. The report stated: “The Agency
did not have adequate monitoring procedures to ensure payments to subrecipients
were for allowable activities and costs.”30
 In Wisconsin, an audit of a Title X grantee found Medicaid overbilling problems,
including no proof of prescription, excessive reimbursements beyond what is
allowable, and other irregularities.31
 In Massachusetts, a Title X grantee was subject to an OIG investigation, where
the grantee admitted to comingling Title X expenses with all other family
planning expenses, a clear violation of Federal requirements.32
These examples raise concerns about the integrity of the Title X program. While only a
few of these cases involve documented misuse of Title X funds or violation of Title X’s
financial requirements, the Department is concerned these instances suggest that at least
some recipients or subrecipients of Title X funds may not understand, and/or may not be
in compliance with, requirements regarding the receipt or use of Federal funds, including
Title X funds.
More broadly, grantees from a variety of federal programs commonly fail to
verify personnel costs with the actual time spent on the grant-supported activities
compared to time spent on non-grant functions by fully documenting time with personnel
30
Nebraska Auditor of Public Accounts, State of Nebraska Statewide single audit: Year ended June 20,
2015 (Mar. 24, 2016), http://www.auditors.nebraska.gov/APA_Reports/2016/SA200-03242016-
July_1_2014_through_June_30_2015_Statewide_Single_Report.pdf.
31
Wisconsin Department of Health Services, Audit Reveals Significant Overpayments to Family Planning
Clinics (Aug. 3, 2016), https://www.dhs.wisconsin.gov/news/releases/fp-summary-results.pdf.
32
HHS OIG, Audit of Tapestry Health Systems, Inc. Title X Financial Management Systems, Report No.
A-01-99-01504 (May 2000), https://oig.hhs.gov/oas/reports/region1/19901504.pdf.
33
activity reports. In addition, it is not uncommon for project costs in federal reports to be
inconsistent with time and status reports or bookkeeping ledgers, or for grantees to lack
adequate documentation for the amount allocated to the grant for indirect costs. Yet
infrastructure costs can benefit the organization generally, rather than only as it pertains
to activities permitted under the grant project.33
The Department believes it necessary to address this issue with expanded
monitoring, reporting, transparency, and accountability requirements. Because of the
specific statutory prohibitions and requirements imposed on Title X projects, and the
regulatory requirement—both currently and as proposed—for financial separation, the
Department does not believe that the general grants management requirements are
sufficient to address the issue. Rather, the Department proposes specific requirements to
ensure legal and ethical usage of taxpayer dollars. These requirements are discussed in
greater detail below, but they include requiring programs to: ensure compliance with
statutory requirements; have a plan in place to demonstrate that grantees and
subrecipients are aware of certain reporting requirements that apply in their state; provide
adequate training with respect to those requirements; maintain records about clients for
whom state reporting requirements apply; receive approval for any change in the usage of
grant funds; and fully account for and justify charges against the Title X grant.
3. Enforcing Other Statutory Requirements on the Use of Title X Funds.
The current regulations also raise concerns about compliance with other federal
laws that govern expenditures of taxpayer funds.
33
National Historical Publications and Records Commission, An introduction to financial management for
grant recipients, National Archives (June 17, 2015) https://www.archives.gov/files/nhprc/pdfs/grant-
financial-management.pdf.
34
In addition to the Anti-Lobby Act, 18 U.S.C. 1913, the Department’s annual
appropriations act establishes a comprehensive framework prohibiting the use of Federal
funding, including Title X funds, for publicity and propaganda. One set of prohibitions
applies across the Executive Branch: “No part of any funds appropriated in this or any
other Act shall be used by an agency of the executive branch, other than for normal and
recognized executive-legislative relationships, for publicity or propaganda purposes, and
for the preparation, distribution or use of any kit, pamphlet, booklet, publication, radio,
television, or film presentation designed to support or defeat legislation pending before
the Congress, except in presentation to the Congress itself.”34 Another provision applies
to federal contractors: “No part of any appropriation…shall be used directly or indirectly,
including by private contractor, for publicity or propaganda purposes within the United
States not heretofore authorized by Congress.”35
Yet another provision, which expressly applies to the Departments of Labor,
Health and Human Services, and Education, adds “electronic communication” and
substitutes “video” for “film” in the list of prohibited media, sweeps into its ambit “any
State or local legislature or legislative body,” and adds “any proposed or pending
legislation, administrative action, or order issued by the executive branch of any State or
local government” to the prohibited targets.36 This prohibition is coupled with the
directive that no part of the Labor, HHS, and Education appropriation “shall be used to
pay the salary or expenses of any grant or contract recipient, or agent acting for such
34
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. E, sec. 715, 132 Stat. 348, 590 (2018).
35
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. E, sec. 718, 132 Stat. 348, 591 (2018).
36
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 503(a), 132 Stat. 348, 762 (2018).
35
recipient” who engages in a similar list of lobbying activities.37 The Appropriations Act
also contains an explicit prohibition against the use of Title X funds “for any activity
(including the publication or distribution of literature) that in any way tends to promote
public support or opposition to any legislative proposal or candidate for public office.38
Finally, the Byrd Amendment applies to the recipients of Federal contracts,
grants, or loans, as well as the funded parties to cooperative agreements. It prohibits them
from using such funds to lobby in connection with the award, extension, continuation,
renewal, amendment, or modification of the funding mechanism under which monetary
assistance was received.39
The current regulations offer no guidance on the application of these restrictions
to the Title X program. Yet these restrictions on the use of appropriated funds clearly
prohibit the use of Title X funds to encourage, promote, or advocate for abortion, to
support any legislative proposal that encourages abortion, or to support or oppose any
candidate for public office. Without guidance from the Department, it is possible that
Title X grantees could intentionally, or unintentionally and unknowingly, use Title X
funds for prohibited lobbying or political activities, or use such funds to support or pay
dues/association fees to organizations where a majority of funds are used for such
purposes. Indeed, issues surrounding family planning and abortion are highly
controversial and routinely the subject of debate and policy consideration in the political
and legislative processes at the national, state and local levels. As a consequence, and
37
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 503(b), 132 Stat. 348, 763 (2018).
38
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, Title II, 132 Stat. 348, 716-717 (2018);
Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017).
39
31 U.S.C. 1352(a).
36
even without consideration of violations of these requirements, it is important that
recipients of Title X funds fully understand the statutory prohibition on the use of Federal
funds for lobbying and political activity.
The proposed rule would provide more explicit direction, in requiring Title X
grantees to provide a written assurance that they both understand and agree to the
prohibitions related to lobbying and political activity with the use of grant funds. Because
of the specific statutory prohibitions applicable to Title X, and the regulatory
requirement—both currently and as proposed—of financial separation, the Department
does not believe that the general grants management requirements would be sufficient to
address the issue.
D. Inadequate Grant Review Criteria.
The current Title X regulations set forth application review criteria that give HHS
significant flexibility in determining awards, but need to be updated to more fully ensure
that successful applicants both meet the statutory requirements of the Title X program
and are adequately responsive to the statutory goals and purposes of the Title X program.
The statute sets forth several factors that HHS shall take into account in making grants
and contracts,40 but these factors are nonexclusive: The statute does not prohibit HHS
from taking other factors into account and does not specify how much weight to attribute
to each factor. The current regulations similarly contain a non-exclusive list of
application review criteria—which include, but go beyond the statutory criteria—and do
40
Title X provides that, “[i]n making grants and contracts under this section the Secretary shall take into
account the number of patients to be served, the extent to which family planning services are needed
locally, the relative need of the applicant and its capacity to make rapid and effective use of such
assistance.” PHS Act Sec. 1001(b); 42 U.S.C. 300(b).
37
not specify how much weight to attach to each factor, giving HHS discretion to vary the
weighting of the criteria in its competitions.
As a result, while the statute and current regulations give HHS discretion in
considering and weighting factors, the application review criteria in the regulation could
be more comprehensive and rigorous, so that the strongest prospective grantees are more
likely to be selected, and less qualified applicants would be less likely to garner high
scores. The Department is focused on ensuring compliance with the statutory Title X
requirements (see 42 U.S.C. 300-300a-6; Consolidated Appropriations Act, 2018, Pub. L.
115-141, Div. H, Title II, secs. 207-08, 132 Stat. 348, 716-17, 736), including the
program integrity provisions referenced elsewhere herein; expanding the type and nature
of the Title X providers and ensuring the diversity of such providers, so as to fill gaps in
and expand family planning services offered through Title X; and using review criteria as
a meaningful instrument to assess the quality of the applicant and the application. These
goals, which are consistent with the statute and permissible under the existing
regulations, would be best achieved by amending the regulations to more fully specify the
application criteria, while still adhering to the statutory requirement that certain factors be
considered and maintaining the Department’s flexibility to consider other factors in
making awards.
Therefore, through the proposed rule, the Department seeks to achieve a two-fold
goal:
1. Update application review criteria to better achieve the statutory requirements
and goals of Title X.
38
2. Increase competition and rigor among applicants, encouraging broader and
more diverse applicants and better ensuring the selection of quality applicants.
The Department and OPA desire to award grants for the establishment and operation of
those Title X projects that would best promote the purposes of Title X and meet the
statutory requirements.
The Department proposes revising the current application review criteria at 45
CFR § 59.7 through this rulemaking process to establish the following criteria for
selection of Title X grantees. Under this proposed regulation, any grant applications that
do not clearly address how the proposal will satisfy the requirements of the regulation
would not proceed to the competitive review process, but would be deemed ineligible for
funding. The Department would explicitly summarize each provision of the regulation (or
include the entire regulation) within the Funding Announcement, and would require
applicants to describe their affirmative compliance with each provision. If a proposal is
deemed compliant with the regulation, then applicants would be rated based on at least
the following criteria for selection within the competitive grant review process:
(1) The degree to which the applicant’s project plan adheres to the Title X
statutory purpose and goals for the “establishment and operation of voluntary family
planning projects which shall offer a broad range of acceptable and effective family
planning methods and services (including natural family planning methods, infertility
services, and services for adolescents)” (PHS Act Sec. 1001(a), 42 U.S.C. 300(a)), which
meet all of the statutory and regulatory requirements and restrictions, and where “none of
the funds…shall be used in programs where abortion is a method of family planning.”
(PHS Act Sec. 1008, 42 U.S.C. 300a-6).
39
(2) The degree to which “the relative need of the applicant” (PHS Act Sec.
1001(b), 42 U.S.C. 300(b)) is demonstrated in the proposal, and the applicant shows
capacity to “make rapid and effective use” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)), of
grant funds, including and especially among a broad range of partners and diverse
subrecipients and referral individuals and organizations, and among non-traditional Title
X partnering organizations.
(3) The degree to which the applicant takes into account “the number of patients
to be served” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)), while also targeting areas that
are more sparsely populated and/or places in which there are not adequate family
planning services available.
(4) “The extent to which family planning services are needed locally” (PHS Act
Sec.1001(b), 42 U.S.C. 300(b)) and the applicant proposes innovative ways to provide
services to unserved or underserved patients.
The Department seeks public comment as to whether additional regulatory
application review criteria may be necessary or advisable to implement the Department’s
interpretation of the statutory provisions applicable to Title X, in particular section 1008;
to protect the rights of individuals and entities who decline to participate in abortion-
related activities; or to ensure that all services funded through Title X offer optimal health
benefits to clients of all ages. The Department also seeks public comment as to whether
the protections and services funded through Title X are adequately implemented and
clearly understood throughout the Title X program, in order to alleviate the current
confusion, and avoid future confusion, among clients and the general public.
III. Statutory Authorities
40
The Department has legal authority to amend Title X regulations on the
requirements applicable to projects for family planning services under section 1006 of the
Public Health Service Act, 42 U.S.C. 300a-4. Section 1006 of the Act states that “[g]rants
and contracts made under this title shall be made in accordance with such regulations as
the Secretary may promulgate.” The Department has repeatedly exercised that authority
to issue regulations to guide Title X grantees in carrying out the program.
The proposed regulations described below in the section-by-section discussion of
the proposed rule would clarify, require compliance with, and provide for the
enforcement of, statutory limitations and requirements placed on Title X projects and
grantees. These include section 1008 of the Act, which prohibits “funds appropriated
under this subchapter” from being “used in programs where abortion is a method of
family planning” and has been reiterated through annual appropriations provisos that
“amounts provided to said [voluntary family planning] projects, under such title shall not
be expended for abortions.” See, e.g., Consolidated Appropriations Act, 2018, Pub. L.
115-141, Div. H, Title II, 132 Stat. 348, 716 (2018); Consolidated Appropriations Act,
2017, Pub. L. 115-31, Div. H, Title II, 131 Stat. 135, 521 (2017); Consolidated
Appropriations Act, 2016, Pub. L. 114-113, Div. H, Title II, 129 Stat. 2242, 2602 (2015).
They also include annual appropriations provisions directing that “all pregnancy
counseling shall be nondirective”41 and that Title X funds “shall not be expended for any
41
Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, Title II, 132 Stat. 348, 716 (2018).
Nondirective counseling has been described in Congressional proceedings and debates throughout the
years. For example, “nondirective counseling is the provision of information on all available options
without promoting, advocating, or encouraging one option over another.” Congressional Record (1992,
April 30). Family Planning Amendments Act of 1991, House of Representatives. 138 Cong. Rec. H2822-
02, 1992 WL 86830. Non-directive counseling does not mean the Title X provider or counselor is
uninvolved in the process, nor does it mean that counseling and education offer no direction, but that clients
41
activity (including the publication or distribution of literature) that in any way tends to
promote public support or opposition to any legislative proposal or candidate for public
office.”42 See, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H,
Title II, 132 Stat. 348, 716-717 (2018).
The proposed regulations also would require compliance with, and provide for the
enforcement of, statutory provisions applicable to the provision of family planning
services to minors and other vulnerable populations. Title X itself requires that, “[t]o the
extent practicable, entities which receive grants or contracts under this subsection shall
encourage familiy [sic] participation in projects under this subsection.” Omnibus Budget
Reconciliation Act of 1981, Pub. L. 97-35, sec. 931(b)(1), 95 Stat. 375, 570 (1981); 42
U.S.C. 300(a). A rider in HHS’s annual appropriations act adds that “[n]one of the funds
appropriated in this Act may be made available to any entity under title X of the PHS Act
unless the applicant for the award certifies to the Secretary that it encourages family
participation in the decision of minors to seek family planning services.” Consolidated
Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018).
It also requires an applicant to certify that it “provides counseling to minors on how to
resist attempts to coerce minors into engaging in sexual activities.” Id. And another
provision in the annual HHS appropriations act states that, “[n]otwithstanding any other
provision of law, no provider of services under title X of the PHS Act shall be exempt
from any State law requiring notification or the reporting of child abuse, child
take an active role in processing their experiences and identifying the direction of the interaction. The Title
X provider/counselor promotes the client’s self-awareness and empowers the client to change and develop
agency over personal circumstances, offering a range of options, consistent with the client’s expressed need
and with the statutory and regulatory requirements governing the Title X program.
42
Pub. L. 107-116, Title II, 115 Stat. 2177, 2186 (2002). .
42
molestation, sexual abuse, rape, or incest.” Consolidated Appropriations Act, 2018, Pub.
L. 115-141, Div. H, sec. 208, 132 Stat. 348, 736 (2018).
Finally, the proposed regulations would require compliance with, and provide for
the enforcement of, several additional laws that protect the conscience rights of
individuals and entities who decline to perform, participate in, or refer for abortions,
including the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe Amendment
(section 245 of the Public Health Service Act, 42 U.S.C. 238n), and the Weldon
Amendment, see, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H,
sec. 507(d), 132 Stat. 348, 764 (2018); Consolidated Appropriations Act, 2017, Pub. L.
115-31, Div. H, sec. 507(d), 131 Stat. 135, 521 (2017) (collectively, the “conscience
statutes”). The Church Amendments, for example, prohibit grantees from discriminating
in the employment of, or the extension of staff privileges to, any health care professional
because she refused, because of her religious beliefs or moral convictions, to perform or
assist in the performance of any lawful sterilization or abortion procedures. They also
prohibit individuals from being required to perform or assist in the performance of any
health service program or research activity funded in whole or in part under a program
administered by the Secretary contrary to her religious beliefs or moral convictions.43 The
43
In addition, section 300a-7(c)(1) provides that “[n]o entity which receives a grant, contract, loan, or loan
guarantee under the [Act] . . . may (A) discriminate in the employment, promotion, or termination of
employment of any physician or other health care personnel, or (B) . . . in the extension of staff or other
privileges to any physician or other health care personnel . . . because he refused to perform or assist in the
performance of . . . [an] abortion” on the grounds that doing so “would be contrary to his religious beliefs
or moral convictions….” 42 U.S.C. 300a-7(c)(1). Section 300a-7(c)(2) provides that “[n]o entity which
receives . . . a grant or contract for biomedical or behavioral research under any program administered by
[HHS]” may discriminate in the employment of or the extension of staff privileges to any health care
professional “because he refused to perform or assist in the performance of” “any lawful health service”
based on religious belief or moral conviction. 42 U.S.C. 300a-7(c)(2). Section 300a-7(d) provides that “[n]o
individual [may] be required to perform or assist in the performance of any part of a health service program
43
Coats-Snowe Amendment prohibits the Federal government and any State or local
government that receives Federal financial assistance from discriminating against any
health care entity (including individual providers) on the basis that the entity refuses to,
among other things, (1) receive training in induced abortion; (2) require or provide
abortion training; (3) perform abortions; (4) provide referral for such abortions or
abortion training; or (5) make arrangements for any such activities. See 42 U.S.C.
238n(a). And the Weldon Amendment prohibits funds made available in HHS’s annual
appropriations act from being “made available to a Federal agency or program, or to a
State or local government, if such agency, program, or government subjects any
institutional or individual health care entity to discrimination on the basis that the health
care entity does not provide, pay for, provide coverage of, or refer for abortions.” It
provides that “health care entity’ includes an individual physician or other health care
professional . . . .” See, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141,
Div. H, sec. 507(d), 132 Stat. 348, 764 (2018).
IV. Provisions of the Proposed Rule
A. Section 59.1 To what programs do these regulations apply?
. . . funded in whole or in part under a program administered by the Secretary of Health and Human
Services” if doing so “would be contrary to his religious beliefs or moral convictions.” 42 U.S.C. 300a-
7(d). Section 300a-7(e) prohibits any entity that receives funding under the PHS Act from denying
admission to, or otherwise discriminating against, “any applicant (including for internships and residencies)
for training or study because of the applicant’s reluctance . . . to counsel, suggest, recommend, assist, or in
any way participate in the performance of abortions . . . contrary to or consistent with the applicant’s
religious beliefs or moral convictions.” 42 U.S.C. 300a-7(e). In addition, section 300a-7(b) provides in part
that “[t]he receipt of any grant, contract, loan, or loan guarantee under the [PHS Act] . . . by any individual
or entity does not authorize any court or any public official or other public authority to require” (1) the
individual to perform or assist in an abortion if it would be contrary to his/her religious beliefs or moral
convictions; or (2) the entity to make its facilities available for abortions, if the performance of abortions in
the facilities is prohibited by the entity on the basis of religious beliefs or moral convictions, or provide
personnel for the performance of abortions if it would be contrary to the religious beliefs or moral
convictions of such personnel. 42 U.S.C. 300a-7(b).
44
Under federal law, including Title X, subrecipients of federal funds who agree to
assist a primary grantee in implementing the grant project are required to comply with the
same requirements that are imposed on the grantee. In order to ensure clarity and full
implementation of the requirements of Title X and its implementing regulations, the
Secretary proposes to amend section 59.1 to make it clear that these regulatory
requirements apply equally to subrecipients and to grantees, that grantees are responsible
for requiring that their subrecipients (and the subrecipients of such subrecipients) agree to
comply with such requirements, and that grantees are responsible for ensuring that their
subrecipients so comply.
Title X authorizes the Secretary to not only award grants but also enter into
contracts to establish and operate voluntary family planning projects. 42 U.S.C. 300(a).
Although contracts are used for Title X training, the Department is not aware of a history
of establishing or operating Title X family planning projects by use of contracts instead
of grants. Nevertheless, because the use of contracts to establish and operate family
planning projects is explicitly authorized in the statute, the Department believes that the
regulations should state that the substantive requirements for Title X family planning
projects apply to projects whether they are established by grants or contracts. Therefore
these rules propose to specify in § 59.1 that, except for §§ 59.3, 59.4, 59.8, and 59.10, the
regulations of this subpart would also be applicable to the execution of contracts under
Title X to assist in the establishment and operation of voluntary family planning projects.
Applicable regulations would be applied in accordance with the statutes, procedures, and
regulations that apply to the execution of a Federal contract, as distinct from a grant.
Section 59.1 would specify that the use of the terms “grant,” “award,” “grantee,” and
45
“subrecipient” in applicable regulations of this subpart would apply similarly to contracts,
contractors and subcontractors, and the use of the term “project” or “program” would also
apply to a project or program established by use of a contract. The Departments would
specify that §§ 59.3, 59.4, 59.8, and 59.10 would not apply to contracts, because those
sections generally describe processes specifically applicable to grants and grant
applications, as distinct from the substantive requirements of the other sections of this
subpart. Because of the lack of a history of using contracts to establish or operate Title X
projects, and because Title X funds used for a contract would offset funds used for a
grant, the Department does not believe that specifying that these regulations also
generally apply to Title X contracts would affect the regulatory or economic impact of
these proposed rules. The Department invites comment on the applicability of these
regulations to contracts for the provision of family planning services under Title X.
B. Section 59.2 Definitions.
The current Title X regulations include a limited number of definitions that are
very general in scope including “Act,” “family,” “low-income family,” “nonprofit,”
“Secretary,” and “state.” Important terms, such as “family planning,” “grantee,” and
“subrecipient,” are not defined. The Department believes that, as a result of these
omissions, the Title X regulations fail to provide sufficient clarity for prospective
grantees and subrecipients, current grantees and subrecipients, and the general public. To
ensure greater clarity and accountability in the use of Title X funds, the Secretary
proposes the addition of four new definitions to the Title X regulations, 42 CFR § 59.2:
⦁ Family Planning
⦁ Grantee
46
⦁ Program or Project
⦁ Subrecipient
Under the proposed regulations, “family planning” would be defined as “the
voluntary process of identifying goals and developing a plan for the number and spacing
of children and the means by which those goals may be achieved. These means include a
broad range of acceptable and effective choices, which may range from choosing not to
have sex to the use of other family planning methods and services to limit or enhance the
likelihood of conception (including contraceptive methods, and natural family planning
or other fertility awareness-based methods), and the management of infertility (including
adoption). Family planning services include preconceptional counseling, education, and
general reproductive and fertility health care to improve maternal and infant outcomes,
and the health of women, men, and adolescents who seek family planning services.
Family planning and family planning services are never coercive and are strictly
voluntary. Family planning does not include post-conception care (including obstetric or
prenatal care) or abortion as a method of family planning. Family planning, as supported
under this subpart, should reduce the incidence of abortion.”
The Department believes that this proposed definition, which largely tracks the
definition of “family planning” in the 1988 Regulations, would provide greater clarity to
grantees and subrecipients as to the type of activities that can be provided by projects
funded under Title X. It is clear that Congress intended the term “family planning” to be
broader in scope than simply contraception; natural family planning and infertility
services are included as mandatory services explicitly enumerated in section 1001(a).
Physical examinations, breast and cervical cancer screenings, sexually transmitted
47
disease (STD) and human immunodeficiency virus (HIV) testing, and pregnancy testing
and counseling would continue to be authorized by this definition under the rubric of
“general reproductive and fertility health care.” The proposed definition includes
concepts from the 1988 rule identifying family planning as a process of establishing
objectives for the number and spacing of children and the means of achieving those
objectives. The proposed definition elaborates on “objectives” by specifying they involve
both goals and plans, as inherent in the term family “planning.” The definition specifies
that the process is “voluntary,” “strictly voluntary,” and “never coercive,” consistent with
the statutory requirement that Title X apply only to “voluntary” family planning. The
definition specifies that family planning includes management of infertility (including
adoption). Both this definition and the 1988 definition include general reproductive
health care.44 The 1988 definition elaborated that it included diagnosis and treatment of
infections which threaten reproductive capability. This proposed definition would include
that aspect of reproductive health care, as well as the goal of improving maternal and
infant outcomes and the health of those who seek family planning services.
The other newly proposed definitions are designed to provide greater clarity
concerning which entities are subject to the provisions of Title X.
The Department proposes that “project” or “program” be defined as a plan or
sequence of activities that fulfills the requirements elaborated in a Title X funding
44
The Department is aware that, in the international context, the term “reproductive health care” is often
used to encompass abortion and related services. Given the long-standing prohibition on the use of Title X
funds for programs/projects where abortion is a method of family planning and the focus of the Title X
program on pre-conception care, the Department does not use the term in such a manner; in the Title X
context, “reproductive health” or “reproductive health care” does not encompass abortion or abortion-
related services.
48
announcement and may be comprised of, and implemented by a single grantee or
subrecipient, or a group of partnering providers who, under a grantee or subrecipient,
deliver comprehensive family planning services that satisfy the requirements of the grant
within a service area. These proposed definitions are consistent with current Title X
program practices.45
The Department proposes definitions of “grantee” and “subrecipient” because
confusion surrounds their meanings. In this proposed rule, “grantee” would mean the
entity that receives Federal financial assistance through a grant and assumes legal and
financial responsibility and accountability for the awarded funds and for the performance
of the activities approved for funding and for making the required reports to OPA.
A clear definition of “subrecipient” is necessary to ensure program integrity
related to both financial and programmatic requirements. Title X service sites (i.e.,
clinics) that provide Title X services directly to individuals may receive Title X grant
monies from the grantee (or another subrecipient) as a secondarily named provider or as
an agency that provides services, but may not be specifically named within the grant
application. There is a need for transparency that currently does not exist. The
Department does not have an accurate understanding of any grantee’s subrecipients, of
what role each subrecipient plays in the overall function of the Title X project, or of the
extent to which Title X funding supports the efforts of the subrecipient. Additional
transparency would help to ensure accountability for, and wise use of, taxpayers’ money.
Current Title X regulations, however, do not require grantees to submit information to the
45
See, e.g., “Definitions” section of the “Program Requirements for Title X Funded Family Planning
Projects,” Version 1.0 (April 2014), https://www.hhs.gov/opa/sites/default/files/ogc-cleared-final-april.pdf.
49
government about their subrecipients, referral agencies, or other partners to whom Title X
funds may flow. This lack of information is a barrier to OPA’s oversight of the activities
of its program and project subrecipients and, ultimately, to governmental accountability
for those funds.
Therefore, the Department proposes to define “subrecipient” as any entity that
provides family planning services with Title X funds under a written agreement with a
grantee or another subrecipient. These subrecipients have entered into binding
agreements or other financial relationships with Title X grantees to provide Title X
services in a given State or community. A “[s]ubrecipient” may also be referred to as a
“delegate” or “contract agency.” These entities receive Title X funds to provide Title X
services, and are subject to the Title X statute and regulations. This proposed definition
would help clarify the entities that receive Title X monies, how they use these funds, and
how their services comply with the purpose of the Title X program. In addition, the
definition would elucidate the relationship between the grantees and their subrecipients,
and would convey, along with the proposed changes to section 59.1, that grantees are
responsible for ensuring that their subrecipients (and the subrecipients of such
subrecipients) comply with all statutory and regulatory requirements.
To the extent an entity receives Title X funds from a grantee or a subrecipient, it
receives funds to provide Title X services, and is thus a subrecipient subject to the Title X
statute and regulations. By contrast, some referral agencies do not receive funds from the
Title X grant program, but may nevertheless provide information, counseling, or services
to a Title X client. A referral agency or individual is a person or entity which is a
specialist in a certain field of service and to whom the Title X project refers patients for
50
additional services not available at the Title X clinic site, or not adequately available at
the site, to serve the immediate needs of the patient. For example, an individual may visit
the Title X clinic for contraceptive services, but in the course of conversation, it may be
revealed that the individual wants to end a current intimate and unhealthy relationship. In
this case, a referral could then be made to an entity that has expertise in relationship
counseling beyond what is available in this Title X clinic. In this and similar cases, the
referral agencies would not be considered subrecipients, since they do not receive Title X
funds. But because such services are an extension of the overall Title X service provision,
in certain cases referral agencies participate in, and receive intrinsic non-monetary
benefits as a result of, a formal or informal partnership with a Title X project.
Accordingly, we seek comment on whether such a referral agency should be subject to
the same reporting requirements as a grantee or subrecipient—by means of requiring
grantees and subrecipients to use referral agencies only if they require the referral
agencies to submit the required information. This could apply if the referral agency:
⦁ has a written agreement with the grantee or another subrecipient;
⦁ specifically uses its inclusion in the Title X project to expand its influence in the
community; or
⦁ conducts its services, activities, or communications in such a way that its
participation in the Title X project is central, or very important, to its existence.
Finally, this proposed rule would amend the definition of “low income family” to
include women who are unable to obtain certain family planning services under their
employer-sponsored health insurance policies due to their employers’ religious beliefs or
moral convictions. This would preserve conscience protections for entities and
51
individuals whose health plans are subject to a mandate of contraceptive coverage
through guidance issued pursuant to the Patient Protection and Affordable Care Act,
while providing free or low-cost family planning services for such women at risk of
unintended pregnancy or who otherwise desire comprehensive, holistic, family planning
services.
The proposed definition of “low income family” would maintain the ability of a
Title X project to determine whether unemancipated minors who desire confidential
services are low income based on their own resources. However, to ensure compliance
with the statutory requirement that Title X projects encourage family participation in the
decision of minors to seek family planning services, Title X clinics would be required to
document in the minor’s medical records the specific actions taken with respect to each
minor to encourage such family participation. Documentation of such encouragement
would not be required if the Title X clinic documents in the medical record that (1) the
minor is suspected to be the victim of child abuse or incest and (2) it has, consistent with
and if permitted or required by applicable State or local law, reported the situation to the
relevant authorities.
C. Section 59.3 Who is eligible to apply for a family planning services grant or
to participate as a subrecipient as part of a family planning project?
Consistent with the requirements of the Joint Resolution of Disapproval, signed
by the President on April 13, 2017 (referenced above), the Department proposes to revise
the heading and remove paragraph (b) of section 59.3. Because of the joint resolution of
disapproval, the Department is prohibited from reissuing the nullified 2016 Regulation in
“substantially the same form” or issuing a “new rule that is substantially the same” as the
52
nullified 2016 Regulation. 5 U.S.C. 801(b). This proposed rule does not seek to re-issue
the nullified provision at all, much less in substantially the same form, nor does the
Department seek to issue, in this rulemaking, a new rule that is substantially the same as
the nullified provision.
D. Section 59.5 What Requirements Must be Met by a Family Planning Project?
Section 1001(a) of the Title X statute requires Title X projects to “offer a broad
range of acceptable and effective family planning methods and services (including
natural family planning methods…).” The current regulations state, somewhat differently,
that projects must “[p]rovide a broad range of acceptable and effective medically
approved family planning methods (including natural family planning methods) and
services (including infertility services and services for adolescents),” and note that “[i]f
an organization offers only a single method of family planning, it may participate as part
of a project as long as the entire project offers a broad range of family planning services.”
42 CFR § 59.5(a)(1).
The current regulation, while worded differently than the statute, does not
override the statutory requirement that projects offer “a broad range of acceptable and
effective family planning methods and services (including natural family planning
methods…).” 42 U.S.C. 300(a). Although the current regulations require that projects
provide, at a minimum, a broad range of “medically approved” family planning methods,
they do not preclude the Department from requiring more, namely, as the statute
provides, “a broad range of acceptable and effective family planning methods and
services (including natural family planning methods . . . ).” Moreover, the current
regulations do not define “medically approved,” and have not required that a family
53
planning method be regulated, approved, or certified by any particular agency or
accreditation body. If a family planning method is, as required by the statute, “acceptable
and effective,” it is likely to be approved by at least some medical sources. For example,
in March 2016, the American College of Obstetricians and Gynecologists (ACOG)
launched the “Women’s Preventive Services Initiative.” In its “Clinical
Recommendations,” ACOG recommended that instruction in fertility awareness-based
methods of family planning, and counseling, initiation of use, follow-up care,
management, and evaluation of the same, be provided with no cost-sharing in health
coverage.46 The Health Resources and Services Administration (HRSA), a component of
HHS, adopted this recommendation on December 20, 2016, and added coverage of
fertility awareness based methods of family planning to its women’s preventive services
guidelines, issued pursuant to Section 2713(a)(4) of the Affordable Care Act (42 U.S.C.
300gg-13(a)(4)).47 On this basis, fertility awareness-based methods of family planning
could be said to be “medically approved.” Medical doctors and professional organizations
can differ on which methods of health care they approve, including different methods of
family planning. Such differences may be based on differing areas of expertise, or
differing views of the health care method.
Similarly, certain family planning methods or services may not fall under the
regulatory jurisdiction or expertise of some government agencies. The Food and Drug
Administration has regulatory jurisdiction over drugs, biologics, and medical devices. As
46
See Women’s Preventive Services Initiative, Clinical Recommendations, American College of
Obstetricians and Gynecologists,
https://www.womenspreventivehealth.org/recommendations/contraception.
47
See HRSA, Women’s Preventive Services Guidelines, https://www.hrsa.gov/womens-guidelines-
2016/index.html.
54
such, while it has regulatory authority over and approves or clears contraceptive drugs
and devices, FDA would not necessarily have regulatory jurisdiction over, or an approval
process for, other family planning methods. Some fertility awareness-based methods of
family planning might be a drug or device, such as certain fertility awareness kits that are
or contain a medical device.48 Other fertility awareness-based methods of family planning
might not be drugs or devices, use drugs or devices, or be sold in conjunction with drugs
or devices. Some methods might be merely instructional, or might include the
recommendation that certain kinds of drugs or devices be used, without the “method”
itself being a drug or device. When HRSA added fertility awareness-based methods of
family planning and counseling to its women’s preventive services guidelines, it did so
even though the guidelines already included all FDA-approved contraceptive and
sterilization methods, because the birth control methods FDA has approved or cleared are
all drugs and devices.49 The fact that non-drug and non-device fertility awareness-based
methods of family planning are not on FDA’s list of approved birth control methods does
not mean that such fertility awareness-based methods are not “medically approved,” but
rather means that they are not drugs or medical devices, and, thus, not under FDA’s
jurisdiction and not subject to FDA’s approval or clearance.
The Department proposes to revert to the statutory language that Title X projects
“offer a broad range of acceptable and effective family planning methods and services.”
In so doing, the proposed rule would remove the language specifying that the family
48
See FDA Enforcement History,
https://www.fda.gov/iceci/enforcementactions/enforcementstory/enforcementstoryarchive/ucm106947.htm
(“Warning Letter Issued for “Fertility Awareness Kit”).
49
See FDA,
https://www.fda.gov/ForConsumers/ByAudience/ForWomen/FreePublications/ucm313215.htm.
55
planning methods and services offered by a Title X project be “medically approved.”
That language does not appear in the statute and may cause confusion about the type of
family planning methods or services that a project may or should provide, and the type of
approvals (if any) necessary before a Title X project can provide such method or service.
The statutory language of “acceptable and effective family methods or services” provides
better guidance for the types of methods and services that Congress sought to fund.
The proposed rule would also make it more explicit that the requirement to
provide a “broad range” of acceptable and effective family planning methods and
services does not require a project to provide every acceptable and effective family
planning method or service. The meaning of “broad range” has been the subject of
inquiries from grantees and lawmakers at all levels of government, as well as from
members of the public, and has resulted in potentially inconsistent interpretations of the
“broad range” mandate. Some have interpreted the “broad range” requirement of section
1001(a), as well as of 42 CFR § 59.5(a)(1), to require that a project provide all forms of
family planning approved or cleared by the Food and Drug Administration (FDA). The
plain language of the statutory (and regulatory) requirements, however, does not require
projects to provide every acceptable and effective family planning method or service (or,
under the current regulation, acceptable and effective medically approved family
planning methods and services), but rather a broad range of such methods and services.
Not every grantee or subrecipient can provide—or should be required to
provide—all services. The proposed rule would also make it more explicit that the
requirement to provide a “broad range” of acceptable and effective family planning
methods and services does not require a project to provide every acceptable and effective
56
family planning method or service. This proposed change reflects the fact that, as the
range of available family planning methods has significantly increased over the last few
decades, it has become increasingly difficult and expensive for a Title X project to offer
all acceptable and effective forms of family planning. Indeed, family planning projects
are confronted with a variety of pharmacological, technological, or medical device
options to consider in service delivery, with widely varying costs. Staffing limitations,
technological capacity, economics (including costs and demand), and conscience
concerns may be taken into account when grantees or subrecipients determine which
methods they will offer within their scope of services. For example, natural family
planning (NFP) services (and other fertility-awareness based methods) are a recognized
form of family planning services under the statute, but many couples or families seeking
these services may prefer specialized, single-method NFP service sites. Other sites
serving men may offer only family planning methods relevant to that population. Another
site may be a hospital satellite location which is primarily diagnostic in function,
although it also offers some on-site family planning services. Such sites are permissible
as components of a Title X family planning project, as long as the overall project
provides a broad range of acceptable and effective family planning methods and services.
In these examples, some participants in the Title X project offer specialized services, but
not a broad range of family planning methods and services. However, such limited family
planning service offering is permissible as long as the overall Title X project offers a
broad range of family planning services, including contraceptives.50
50
The Department notes that the Title X statute would not permit a Title X project to provide only one (or a
limited number of) family planning methods and services.
57
Thus, under the proposed rule, no Title X project would be required to provide
every acceptable and effective family planning method or service, but all Title X projects
would be required to provide a broad range of family planning methods. Family planning
methods which are permitted with Title X funds include (but are not limited to): male
condom, spermicide, cervical cap, fertility awareness based methods, female condom,
diaphragm, vaginal contraceptive ring, IUD, oral contraceptives, shot/injection,
implantable rod, vasectomy, and sexual risk avoidance (or avoiding sex). Under the
proposed rule, any organization that desires to provide only a single method, or limited
number of methods of family planning, may participate, as long as the Title X project as a
whole offers a broad range of family planning methods and services. Title X specifically
identifies natural family planning, infertility services, and services for adolescents, as
voluntary family planning services that Title X projects “shall offer,” 42 U.S.C. 300(a),
making these family planning methods and services mandatory for each Title X project
(although, as discussed elsewhere herein, it is not required that each provider within a
project offer each method). That is, included in the broad range of acceptable and
effective family planning methods and services that each Title X project must offer are
natural family planning methods, infertility services, and services for adolescents.
The proposed rule would also remove the requirement that past grantees be
consulted for new services or projects in their locale as set forth in (a)(10)(i) of the
current regulation. We believe that removing this requirement would encourage a broader
range of applicants and permit innovative approaches that may not have been envisioned
or supported by past grantees. While communication and coordination is often beneficial
and encouraged, removing the requirement for consultation is intended to have the effect
58
of loosening the status quo for service provision in a community in favor of a broader
reach in order to previously underserved populations.
The proposed rule would make it clear that, as contemplated by the statute, family
planning is not limited to, or synonymous with, access to various methods of
contraception, but includes a broader understanding of family planning methods and
services. Family planning services should fit the family planning needs of the individual,
and/or couple (if applicable). And in order to promote a holistic approach to family
planning and reproductive health, the proposed rule would inform Title X service
providers that they should offer either comprehensive primary health services onsite or
have a robust referral linkage with primary health providers who are in physical
proximity to the Title X site. This provision decreases the overall cost and transportation
challenges related to access for vital health care services that may be discovered as a
result of routine family planning screening and consultation. Title X service providers
should ensure that they have a broad range of partners and diverse subrecipients in order
to make it easier for all clients, particularly low income clients, to access necessary
medical services and related educational and counseling services, as stipulated by the
statute and as necessary to ensure that screening, diagnosis, and treatment can be
provided within close proximity of the clinic, and to ensure that the most needy have
access to care.51
51
A 2013 Child Trends Research Brief, “The Health of Women Who Receive Title X supported family
Planning Services” found that 60% of women receiving care at Title X clinics report that the clinic is their
primary source for health care, yet many fear they cannot address other health concerns with their family
planning provider, making the need for a linkage to comprehensive primary care providers essential for
women’s health. The report also found that women who receive care at Title X clinics generally have worse
health than women who receive services elsewhere, and that of such women, (1) over 25% report at least 3
health concerns; and (2) one-third are obese, with an additional 29% being overweight. Since Title X
59
To expand transparency surrounding Title X services, the proposed rule would
require applicants to provide the following within their applications (to the extent secured
at the time of application) and, if funded, in required reports, and in response to
performance measures, wherever practicable:
⦁ Names and locations of subrecipients, referral individuals and agencies, as well as
services provided and to be provided by those entities;
⦁ Detailed descriptions of all partnerships with such entities, including the extent of
any collaboration with subrecipients, referral individuals and agencies—as well as with
less formal partners within the community—in order to demonstrate a seamless
continuum of care for clients;
⦁ A clear explanation of how the grantee will ensure adequate oversight and
accountability for quality and effectiveness outcomes among subrecipients and those who
serve as referrals for ancillary or core services.
In addition, in order to promote compliance with a requirement present in both
Title X itself and the Title X appropriations provisions,52 the proposed rule would require
Title X service providers to encourage family participation in the decision of minors to
family planning services are generally limited to preconception services, it is important that Title X sites
assist clients to achieve optimal preconception health. A large number of women experience unintended
pregnancies, making the inclusion of preconception health screenings in the continuum of family planning
care all the more important for all clients (male and female), not only those seeking pregnancy.
Preconception health care is important because pregnancy may stress and affect extant health conditions;
linkages to comprehensive primary health care may be critical to ensuring that pregnancy does not
negatively impact such conditions. In addition, the greatest risks affecting the health of a baby occur early
in a pregnancy – often before a woman realizes she is pregnant – such that helping women achieve optimal
preconception health is important to ensure healthy pregnancies (as well as healthy babies) should
conception occur.
52
See 42 U.S.C. 300(a); Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 207, 132
Stat. at 736.
60
seek family planning services and to document, in the records maintained with respect to
each minor, the specific actions taken to encourage such family participation (or the
specific reason why such family participation was not encouraged).53
E. Section 59.7 Criteria for Selection of Grantees.
As discussed above, the Department is focused on achieving better integration of
primary and preventive care among a diverse group of applicants, using review criteria as
a meaningful instrument to assess the quality of the applicant and the application. The
current regulations give HHS flexibility in selecting grantees and determining awards, but
could better ensure that review criteria are geared to achieving the selection of grantees
that can best achieve the goals and purposes of the Title X program. Therefore, through
the proposed rule, we would seek to achieve a two-fold goal:
⦁ Update application review criteria to better achieve the statutory requirements and
goals of Title X.
⦁ Increase competition and rigor among applicants, encouraging broader and more
diverse applicants, and better ensuring quality applicants will be selected.
The Department desires to award grants for the establishment and operation of those Title
X projects that would best promote the purposes of Title X and meet the statutory
requirements imposed on Title X projects.
We propose revising the current application review criteria at § 59.7 through this
rulemaking process to update and expand criteria for selection of Title X grantees as
follows. Any grant applications that do not clearly address how the proposal will satisfy
53
Of course, as noted above, the fact that child abuse, child molestation, incest, or the like is suspected and
has been reported to the appropriate authorities, consistent with State or local reporting or notification laws,
would constitute such reason.
61
the requirements of this regulation would not proceed to the competitive review process,
but would be deemed ineligible for funding. The Department would explicitly summarize
each provision of the regulation (or include the entire regulation) within the Funding
Announcement, and would require each applicant to describe their affirmative
compliance with each provision. If the proposal is deemed compliant with the regulation,
then applicants would be subject to criteria for selection within the competitive grant
review process, including:
planning projects which shall offer a broad range of acceptable and effective family planning
methods and services (including natural family planning methods, infertility services, and
services for adolescents,” (PHS Act Sec. 1001(a), 42 U.S.C. 300(a)), which meet all of the
statutory and regulatory requirements and restrictions, and where “none of the funds…shall
be used in programs where abortion is a method of family planning.” (PHS Act Sec.
1008, 42 U.S.C. 300a-6.)
(2) The degree to which “the relative need of the applicant” (PHS Act Sec 1001(b),
42 U.S.C. 300(b)) is demonstrated in the proposal and the applicant shows capacity to “make
rapid and effective use” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)) of grant funds,
including and especially among a broad range of partners and diverse subrecipients and
referral individual and organizations, and among non-traditional Title X partnering
organizations.
62
These proposed criteria would advance compliance with the text and purpose of Title X
by seeking grantees to better serve the targeted population with services that are needed,
focused on family planning in the context of holistic health in both the short and long
term.
The Department seeks public comment as to whether additional regulatory
application review criteria may be necessary or advisable to reflect the text and purpose
of the statutory provisions applicable to Title X, in particular section 1008; to protect the
rights of individuals and entities who decline to participate in abortion-related activities;
or to ensure that all services funded through Title X offer optimal health benefits to
clients of all ages. The Department also seeks public comment as to whether the
protections and services funded through Title X are adequately implemented and clearly
understood throughout the Title X program, in order to alleviate the current confusion,
and avoid future confusion, among clients and the general public.
F. Section 59.11 Confidentiality.
As discussed above, Title X grantees and subrecipients are required to comply
with all State and local laws requiring notification or reporting of child abuse, child
molestation, sexual abuse, rape, incest, and the like. Section 59.11 currently provides that
personal information may not be disclosed absent consent by the individual, except to
63
provide treatment, or as required by law, “with appropriate safeguards for
confidentiality.” To ensure that Title X grantees and subrecipients comply with
applicable reporting requirements, the proposed rule would clarify that concerns about
confidentiality of information may not be used as a rationale for noncompliance with
such reporting laws.
G. Section 59.13 Standards of Compliance with Prohibition on Abortion.
Current Title X regulations at 42 CFR § 59.5(a)(5) state that “[e]ach project
supported under this part must … not provide abortion as a method of family planning.”
However, the Department has determined that such regulations do not provide sufficient
guidance to ensure that Title X projects comply with section 1008 and do not encourage
or promote abortion as a method of family planning. Proposed § 59.13 would accordingly
require that programs seeking Title X funding provide assurance satisfactory to the
Secretary that, as Title X grantees, they do not provide abortions and do not include
abortion as a method of family planning. The proposed rule would also require assurance
that grantees are in compliance with the prohibition on promoting abortion as a method of
family planning; the maintenance of separation of the Title X project from prohibited
activities; and the prohibition on activities that encourage, promote, or advocate for
abortion. These specific requirements are designed to enable the Secretary to obtain, at
the application stage, information relevant to determining whether a program or project
will, in fact, comply with the statutory prohibition. Therefore, under the proposed rule, an
applicant for Title X funds would be ineligible for those funds if it is unable to
demonstrate to the satisfaction of the Secretary that it (and its subrecipients, if applicable)
would comply with the regulations implementing section 1008.
64
H. Section 59.14 Prohibition on Referral for Abortion.
Proposed § 59.14 would expressly prohibit Title X projects from performing,
promoting, referring for, or supporting, abortion as a method of family planning.54 As
discussed above, the Department believes that the current requirement under 42 CFR
§ 59.5(a)(5)(ii) that a project provide abortion referrals to pregnant women upon request
is inconsistent with section 1008, premised on an erroneous notion that the statute is
neutral on the question whether Title X funds may be used to encourage or promote
abortion as a method of family planning, and violative of Federal health care conscience
statutes. The proposed provision would better implement section 1008 and better align
the regulations implementing Title X with those Federal health care conscience statutes.
It would also promote grantee diversity by expanding the number of qualified entities that
would be willing and able to apply to provide Title X services, since potential grantees
and subrecipients that refuse to provide abortion referrals may have been ineligible or
discouraged from applying for Title X grants or seeking to provide family planning
services under a Title X project by the requirements of the current regulations.
Proposed § 59.14 would prohibit referral for abortion as a method of family
planning or any other affirmative action to secure such an abortion in a Title X project.
Under the proposed provision, referrals could not be used as an indirect means to
encourage or promote abortion. In addition, Title X projects do not themselves provide
post-conception care. Thus, proposed § 59.14 would require that pregnant women be
54
In the case of rape and/or incest, it would not be considered a violation of the proposed prohibition on
referral for abortion as a method of family planning if a patient is provided a referral to a licensed,
qualified, comprehensive health service provider who also provides abortion, provided that the Title X
provider has complied with all State and/or local laws requiring reporting to, or notification of, law
enforcement or other authorities and such reporting or notification is documented in the patient’s record.
65
referred outside of the Title X project for prenatal care and other related medical and
social services, as well as for other services relating to pregnancy after pregnancy is
confirmed. In no case would the proposed provision permit a Title X-funded family
planning program to make a referral for, or determine the appropriateness of, abortion as
a method of family planning. As discussed above, a doctor, though not required to do so,
would be permitted to provide nondirective counseling on abortion.55 Such nondirective
counseling would not be considered encouragement, promotion, or advocacy of abortion
as a method of family planning, as prohibited under section 59.16 of this proposed rule.
Moreover, a doctor would also be permitted to provide a list of licensed, qualified,
comprehensive health service providers, some (but not all) of which provide abortion in
addition to comprehensive prenatal care. Providing such a list would be permitted only in
cases where a program client who is currently pregnant clearly states that she has already
decided to have an abortion.56 No participant in the Title X program may promote or
support abortion as an acceptable mechanism of family planning through that Title X
program. Thus, all other patients would be provided a list of licensed, qualified,
comprehensive health service providers (including providers of prenatal care) who do not
provide abortion as a part of their services, along with referrals for prenatal care and
social services.
It is important to recognize that proposed § 59.14 would not prohibit Title X
projects from providing the factual information necessary to assess risks of a particular
55
That counseling on abortion be nondirective is required by the appropriations law applicable to Title X.
See Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, Title II, 132 Stat. at 716-17 (“all
pregnancy counseling shall be nondirective”).
56
The list may not identify in any way the providers that perform abortions in addition to comprehensive
prenatal care.
66
family planning or contraceptive method as set out in the patient package inserts. Neither
would proposed section 59.5, or 59.14 preclude a health care professional from disclosing
to a woman any physical findings the professional has made regarding the woman’s
condition; communicating an assessment of the urgency of the need for treatment; or
ensuring that the woman is referred to the appropriate specialist for treatment of the
condition, including emergent conditions, with adequate follow-up provided. Further, the
proposed provision does not propose to alter the current requirement that Title X grantees
and subrecipients provide for “necessary referral to other medical facilities when
medically indicated,” 42 CFR § 59.5(b)(1); see also 42 CFR § 59.5(b)(8); rather, to
further emphasize this requirement, we are proposing to include consistent language in §
59.14. Under this current provision of the Title X regulation, Title X projects must refer
patients directly to a provider of emergency medical services (i.e., hospital emergency
room), when such services are medically indicated. To ensure that such provisions are not
abused in order to provide referral for abortion as a method of family planning, we
propose conforming amendments to section 59.5(b)(1) and (8), which make such referrals
subject to the requirements and prohibitions contained in proposed section 59.14(a).
Further, it is not the intent of the proposed regulatory provision at § 59.14 to
restrict the ability of health professionals to communicate to a patient any information
they discover in the course of physical examination or otherwise about her medical
condition, such as a condition that might make her extant pregnancy high risk. Nor would
the provision preclude a health professional from disclosing to the woman any physical
findings he or she has made regarding her condition and communicating his or her
assessment of the urgency of her need for treatment or action, consistent with the exercise
67
of his or her professional judgment, although the treatment or action might fall outside
the parameters of the Title X program. Read together, proposed § 59.14 and current
§ 59.5(b)(1) would require that, if a woman who comes to a Title X-funded family
planning program is confirmed to be pregnant, she must be referred externally for
services related to her pregnancy. The program would be permitted to provide her with a
listing of licensed health care providers of appropriate prenatal medical care and delivery
services, from which she may choose. But Title X projects would not directly or
indirectly encourage or promote abortion as a method of family planning through the
manner in which referrals are made, or the manner in which such list is constructed. As
noted above, we propose conforming changes to § 59.5(a)(5).
I. Section 59.15 Maintenance of Physical and Financial Separation.
Proposed section 59.15 would create a requirement of both physical and financial
separation between Title X services and any abortion services provided by the Title X
grantee or subrecipient. As noted above, the current Title X program only requires
financial (or bookkeeping) separation between Title X services and any abortion services
provided by the Title X grantee or subrecipient. In accordance with section 1008, the
Department wishes to ensure, among other things, that there is a clear separation between
Title X services and any abortion services provided by a Title X grantee or subrecipients
and that Title X funds are not being used to build infrastructure that supports, or may be
used to support, the separate abortion business of a Title X grantee or subrecipient.
Proposed § 59.15 would require that Title X projects be physically and financially
separate from programs in which abortion is provided or presented as a method of family
planning, including programs that refer for abortions and programs that encourage,
68
promote or advocate abortion as a method of family planning. It would describe relevant
criteria that the Secretary proposes to use in determining whether a project has
demonstrated sufficient separation from prohibited activities. Thus, proposed § 59.15
would prohibit locating a Title X supported family planning program in a fashion which
would not be physically and financially separate. This proposed standard would take into
account the degree of separation of, among other things, waiting, consultation,
examination, and treatment areas—as well as telephone numbers, email addresses, any
official communication devices, including social media, or websites. Thus, under the
proposed provision, an impermissible use of Title X funds might occur when the physical
facility of a grantee or subrecipient organization’s Title X-funded family planning
program shares space with any abortion-related operations.
By requiring that Title X projects be physically and financially separate from
abortion-related activities conducted by the grantee or subrecipient, proposed § 59.15
would help facilitate compliance with Section 1008’s prohibition on abortion as a method
of family planning. It would also facilitate the Department’s enforcement against grantees
or subrecipients that do not comply with the statutory requirement that abortion not be a
method of family planning in a Title X project. In particular, proposed § 59.15 would
allow the Department (and grantees) to make better case-by-case determinations about
whether particular Title X projects or clinic locations have sufficient physical and
financial separation from prohibited activities. To determine whether sufficient separation
exists in a particular case, the Department would weigh all relevant factors, including:
(a) The existence of separate, accurate accounting records;
69
(b) The degree of separation from facilities (e.g., treatment, consultation,
examination and waiting rooms, office entrances and exits, shared phone
numbers, email addresses, educational services, and websites) in which prohibited
activities occur and the extent of such prohibited activities;
(c) The existence of separate personnel, electronic or paper-based health care
records, and workstations;
(d) The extent to which signs and other forms of identification of the Title X
project are present, and signs and materials referencing or promoting abortion are
absent.
Because circumstances or site-specific factors are complex and organizational realities
are varied, the Department would consider individual circumstances unique to a grantee
or Title X provider. We intend to take a case-by-case approach in order to ensure
program integrity, with sensitivity to individual projects and providers, and without
imposing unnecessary requirements. We seek comment on whether additional factors
should be considered, or whether any of the proposed factors should be omitted.
The Department also seeks public comment as to whether additional regulatory
provisions are necessary to reflect the text and purpose of section 1008. Even with a
bright line rule of actual physical separation, confusion could still arise if the separate
facilities – one facility providing Title X services and one providing abortion as a method
of family planning – are operated under the same name. Similarly, the lack of a
requirement of organizational separation could continue to blur the line between
permitted and prohibited Title X services and activities, making enforcement more
difficult. For example, individuals seeking Title X services may mistakenly visit non-
70
Title X sites engaged in activities such as abortion which are actually prohibited by Title
X, but that have the same names and are part of the same organization as the Title X site.
The Department, therefore, seeks public comment as to whether additional regulatory
provisions, such as a requirement for a Title X clinic to operate under a distinct name
from a facility that provides abortion as a method of family planning, or for
organizational separation, are necessary to ensure compliance with section 1008.
J. Section 59.16 Prohibition on Activities that Encourage, Promote or Advocate for
Abortion.
Consistent with the statutory provisions discussed above, and the prohibition in
section 1008 on the use of Title X funds in programs where abortion is a method of
family planning, proposed § 59.16 sets out a number of restrictions designed to ensure
that Title X grantees and subrecipients do not promote or encourage abortion as a method
of family planning using Title X funds. The proposed rule would prohibit the following
actions when undertaken with Title X funds: lobbying, providing speakers that promote
abortion in the project or by the use of project funds, attending events or conferences
during which such lobbying takes place, paying dues to organizations that advocate for
the availability of abortion services, taking legal action to make abortion available as a
method of family planning, and developing or disseminating materials advocating
abortion as a method of family planning or otherwise promoting a favorable attitude
toward abortion. Thus, consistent with proposed § 59.15, any grantee or subrecipient
engaging in these activities with non-Title X funds, would be required to give evidence
that such use of funds is physically and financially separate from the use of Title X funds.
K. Section 59.17 Compliance with Reporting Requirements.
71
New provision § 59.17 would address explicitly the requirement for Title X
projects to comply with all State and local laws regarding the notification or reporting of
crimes involving sexual exploitation, child abuse, child molestation, sexual abuse, rape,
incest, intimate partner violence, and human trafficking. The Consolidated
Appropriations Act, 2018 included the following provision: “Notwithstanding any other
provision of law, no provider of services under Title X of the Public Health Service Act
shall be exempt from any State law requiring notification or the reporting of child abuse,
child molestation, sexual abuse, rape, or incest.” See Consolidated Appropriations Act,
2018, Pub. L. 115-141, Div. H, sec. 208, 132 Stat. 348, 736 (2018); Consolidated
Appropriations Act, 2017, Pub. L. 115-31, Div. H, sec. 208, 131 Stat. 135, 539 (2017);
Consolidated Appropriations Act, 2016, Pub. L. 114-113, Div. H, sec, 208, 129 Stat
2242, 2620 (2015). This provision is consistent with language that has been included in
appropriations acts for HHS since fiscal year 1999. See, e.g., Department of Health and
Human Services Appropriations Act, 1999, Pub. L. 105-277, Title II, sec. 219, 112 Stat.
2681, 2681-363 (1998). The Department interprets this statutory notification/reporting
requirement as encompassing not only any State or local law requiring reporting or
notification dealing with child abuse, child molestation, sexual abuse, rape, or incest, but
also those State or local laws respecting intimate partner violence and human trafficking
because such criminal activities would be encompassed within the categories of crime
enumerated in the Appropriations Act (“child abuse, child molestation, sexual abuse,
rape, or incest”). In addition, the Department interprets this reporting/notification
requirement as applicable to all victims of such crimes, regardless of age, because the
victims of sexual abuse, rape, or incest can be any age. Current Title X regulations permit
72
the use of confidential information obtained by project staff to comply with State and
local reporting requirements,57 but do not expressly address the requirement to report
child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence,
human trafficking, or other sexual exploitation, nor affirmatively impose an obligation on
Title X grantees and subrecipients to comply with State reporting or notification
requirements.
Title X grantees and subrecipients have an affirmative obligation to comply with
notification or reporting requirements; merely being aware of such requirements is
insufficient to comply with the law. As Representative Ernest Istook said during the
debate regarding the provision:
It says, if there is a situation, such as I described, involving an underage child,
Title X providers must report that and comply with State law the same as anyone
else who deals with services to our young people. 143 Cong. Rec. H7053 (1997).
Some practitioners have proposed that providers avoid soliciting or determining the age
of the adolescent or the age of their sexual partner as a means of assuring the adolescent
of confidential services and, thus, avoiding the potential responsibility of reporting. But
Title X exempts neither Title X clinics nor Title X healthcare providers from their
responsibility to comply with State and local reporting laws. Sexual exploitation, abuse,
or assault (including statutory rape) are crimes that affect individuals, families, and
communities. Title X projects should lead the Nation in protecting those who are
vulnerable to sexual abuse, rape, and assault; in developing protocols to identify clients
57
See 42 CFR § 59.11.
73
who may be at risk for sexual abuse; in counseling teens on, and in producing programs
and materials that assist teens in, resisting sexual exploitation, abuse, and coercion58; and
in assuring appropriate support and management of teens (and women) who have been
exploited, abused or coerced into unequal sexual partnerships.
The Department believes that existing efforts to ensure compliance with State and
local reporting laws protecting minors and other vulnerable populations should be
strengthened. While a 2005 report from the Department’s Office of Inspector General
(OIG) revealed that OPA informs and periodically reminds Title X grantees and
subrecipients of their responsibilities regarding State child-abuse and sexual-abuse
reporting requirements, it could not determine the extent to which grantees actually
comply with these requirements.59 Through the proposed rule, the Department would
require, as a condition of receiving Title X funding, that a project provide assurance that
it has a plan in place to comply with State and local laws requiring notification or
reporting and maintains appropriate documentation of compliance with these reporting
requirements.
Proposed § 59.17 would clarify the affirmative duty of Title X grantees and
subrecipients to comply with State and local laws requiring notification or reporting of
child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and
58
As noted above, the annual appropriations laws also impose on Title X recipients the obligation to
provide “counseling to minors on how to resist attempt to coerce minors into engaging in sexual activities.”
See Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, sec. 207, 132 Stat. 348, 736 (2018);
Consolidated Appropriations Act, 2017, Pub. L. 115-31, Div. H, sec. 207, 131 Stat. 135, 538 (2017);
Consolidated Appropriations Act, 2016, Pub. L. 114-113, Div. H, sec. 207, 129 Stat 2242, 2620 (2015).
59
HHS OIG, Letter on Federal Efforts to Address Applicable Child Abuse and Sexual Abuse Reporting
Requirements for Title X Grantees (OEI-02-03-00530) (April 25, 2005),
https://www.hhs.gov/opa/sites/default/files/child-abuse-reporting-requirements.pdf.
74
human trafficking. It would require that Title X grantees and subrecipients have in place
a plan that demonstrates that the grantee and any subrecipients are aware of what specific
reporting requirements apply to them in their State (or jurisdiction), and provide adequate
training for all personnel with respect to these requirements and how such reports are to
be made. As part of prevention, protection, and risk assessment efforts, grantees and
subrecipients should include in such plan protocols to identify individuals who are
victims of sexual abuse or targets for underage sexual victimization and to ensure that
every minor who presents for treatment is provided counseling on how to resist attempts
to coerce minors into engaging in sexual activities. In addition, Title X projects would be
required to conduct a preliminary screening of any teen who presents with an STD,
pregnancy, or suspicion of abuse in order to rule out victimization of a minor. Such
screening would be required with respect to any individual who is under the age of
consent in the jurisdiction in which the individual receives Title X services. If positively
diagnosed, projects are permitted to also treat STDs.
Additionally, proposed § 59.17 would require grantees and subrecipients to
maintain records that would identify, among other things, the age of any minor clients
served, the age of their sexual partner(s) where required by law, and what reports or
notifications were made to appropriate State agencies. The Department would use this
documentation to ensure appropriate compliance with State and local reporting
requirements.
L. Section 59.18 Appropriate Use of Funds.
Consistent with section 1008, proposed § 59.18 would prohibit the use of Title X
funds to build infrastructure of a Title X grantee or subrecipient for purposes outside of
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those permitted under the Title X regulations and authorized within section 1001 of the
Public Health Service Act and not barred by section 1008—that is, to offer family
planning methods and services, which do not include abortion as a method of family
planning. It would clarify that grantees should use the majority of grant funds to provide
direct services to clients and give a detailed accounting for usage related to grant dollars,
both in applications for funding and in any annually required reporting. Under proposed §
59.18, any change in the usage of grant funds within the grant cycle would require the
approval of the Department. In addition, § 59.18 would require each project to fully
account for, and justify, charges against the Title X grant.
As detailed previously, the current flexibility in the usage of Title X funds permits
an interchangeability of assets that grantees may have used to build infrastructure for
non-Title X purposes, including abortion services. This danger is exacerbated because
Title X providers must secure other sources of revenue to leverage Title X grants. See 42
CFR § 59.7(c). Infrastructure building may include physical space, health information
technology systems, including electronic health records, bulk purchasing of contraceptive
and other clinic supplies, clinical training for staff, and community outreach and
recruitment. Title X is the only discrete, domestic, Federal grant program solely focused
on the provision of cost-effective family planning services, and as the number of
Americans at or below the poverty level has increased, the need to prioritize the use of
Title X funds for the provision of family planning services has become only more
important. The Department accordingly proposes (1) to prohibit use of Title X funds for
infrastructure building for purposes outside of the Title X program, (2) to require a
detailed accounting for usage related to grant dollars, and (3) to prohibit any change in
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the use of grant funds without the approval of the Department. In this way, the proposed
section would ensure that Title X funds are used for the purposes expressly mandated by
Congress—that is, to offer family planning methods and services.
M. Section 59.19 Transition Provisions
The Department proposes two different periods of transition to these
requirements. Most of the proposed changes to the Title X regulations are merely
clarifications of existing statutory requirements or impose requirements that would not
seem to require a lengthy period of time for compliance. The Department recognizes,
however, that it might take a longer period of time for grantees and subrecipients to
comply with the proposed requirement to establish and maintain physical separation of
the Title X project from the provision of abortion. Accordingly, the following compliance
dates are proposed to provide a transition period:
 Section 59.15: Requirement for physical separation: One year after the
date of publication of the final rule.
 All other proposed requirements, including the requirement for financial
separation: 60 days following publication of the final rule.
V. Regulatory Impact Statement
A. Introduction and Summary
We have examined the impacts of this proposed rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order
13563 on Improving Regulation and Regulatory Review (January 18, 2011), the
Regulatory Flexibility Act (RFA), section 1102(b) of the Social Security Act, section 202
of the Unfunded Mandates Reform Act of 1995, Executive Order 13132 on Federalism
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(August 4, 1999), the Congressional Review Act, 5 U.S.C. 804(2), section 654, 5 U.S.C.
601 (note), on the Assessment of Federal Regulation and Policies on Families, Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30,
2017), and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
1. Executive Orders 12866 and 13563 and the Congressional Review Act
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits
of available regulatory alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity). Section 3(f) of
Executive Order 12866 defines a “significant regulatory action” as an action that is likely
to result in a rule: (1) having an annual effect on the economy of $100 million or more in
any 1 year, or adversely and materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or state, local or tribal
governments or communities (also referred to as “economically significant”); (2) creating
a serious inconsistency or otherwise interfering with an action taken or planned by
another agency; (3) materially altering the budgetary impacts of entitlement grants, user
fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising
novel legal or policy issues arising out of legal mandates, the President’s priorities, or the
principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be
prepared for major rules with economically significant effects ($100 million or more in
any 1 year). We estimate that this rulemaking is not “economically significant” as
measured by the $100 million threshold. We have prepared a regulatory impact analysis
that, to the best of our ability, presents the costs and benefits of the rulemaking and are
78
including it here in order to provide further evidence of the value of this proposed rule.
This proposed rule has been submitted to the Office of Management and Budget for
review.
2. Regulatory Flexibility Act (RFA)
The RFA requires agencies that issue a regulation to analyze options for
regulatory relief of small entities, businesses, and 501(c)(3) and government entities if a
rule has a significant impact on a substantial number of small entities. The RFA generally
defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small
Business Administration (SBA); (2) a nonprofit organization that is not dominant in its
field; or (3) a small government jurisdiction with a population of less than 50,000. (States
and individuals are not included in the definition of “small entity.”) HHS considers a rule
to have a significant economic impact on a substantial number of small entities if at least
5 percent of small entities experience an impact of more than 3 percent of revenue. HHS
proposed to certify that the proposed rule would not have a significant economic impact
on a substantial number of small entities. Supporting analysis is provided below.
3. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that
agencies prepare a written statement, which includes an assessment of anticipated costs
and benefits, before proposing “any rule that includes any Federal mandate that may
result in the expenditure by State, local, and tribal governments, in the aggregate, or by
the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one
year.” The current threshold after adjustment for inflation is $150 million. HHS does not
expect this proposed rule to result in expenditures that would exceed this amount.
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4. Executive Order 13132
Executive Order 13132 establishes certain requirements that an agency must meet
when it promulgates a rule that imposes substantial direct requirement costs on state and
local governments or has federalism implications. HHS has determined that the proposed
rule, if finalized, would not contain policies that would have substantial direct effects on
the States, on the relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of government. The
proposed changes in the rule represent the Federal Government regulating its own
program. Accordingly, HHS concludes that the proposed rule does not contain policies
that have federalism implications, as defined in Executive Order 13132 and,
consequently, a federalism summary impact statement is not required.
5. Summary of the Proposed Rule
This rule proposes to amend the regulations governing the Title X program to
ensure programmatic compliance and integrity. Specifically, the proposed rule:
(1) Aligns the regulation with the statutory requirements and purpose of the Title
X program, the appropriations provisos and riders addressing the Title X program, and
other obligations and requirements established under other Federal law;
(2) Expands the scope of enforcement and auditing mechanisms available to the
Department to enforce such program requirements; and
(3) Requires individuals and entities covered by this proposed rule to adhere to
certain procedural and administrative requirements that aim to improve client care and
increase transparency.
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(4) We evaluate the effects of this rule over 2019-2023. Costs are estimated to be
$45.5 million in 2019 and $14.6 million in subsequent years. Present value costs of $88.6
million and annualized costs of $21.1 million are estimated using a 3 percent discount
rate; present value costs of $72.4 million and annualized costs of $21.6 million are
estimated using a 7 percent discount rate. The quantified and non-quantified benefits and
costs are summarized in Table 1.
Table 1. Accounting Table of Benefits and Costs of All Proposed Changes
Present Value over 5 Years Annualized Value over 5
by Discount Rate Years by Discount Rate
(Millions of 2016 Dollars) (Millions of 2016 Dollars)
BENEFITS 3 Percent 7 Percent 3 Percent 7 Percent
Quantified Benefits 0 0 0 0
Non-quantified Benefits (see below)

Program integrity of Title X, especially with respect to ensuring that projects and providers do
not fund, support, or promote abortion as a method of family planning. Enhanced compliance
with statutory requirements and appropriations riders and provisos. Expanded number of
entities interested in participating in Title X, including by removal of abortion counseling and
referral requirements that potentially violate federal health care conscience protections.
Enhanced patient service and care.
COSTS 3 Percent 7 Percent 3 Percent 7 Percent
Quantified Costs 88.6 72.4 21.1 21.6
Non-quantified Costs
None
We invite comment on all aspects of this regulatory impact analysis, including the
assumptions and conclusions contained in the analysis.
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B. Analysis of Economic Impacts
1. Need for the Proposed Rule
This proposed rule seeks to address two categories of problems:
(1) Insufficient compliance with the statutory program integrity requirements and
purpose and goals of the Title X program (especially those related to section 1008), the
appropriations provisos and riders addressing the Title X program, and other obligations
and requirements established under other Federal law; and
(2) Lack of transparency regarding the provision of services (with respect to both
the identity of the providers and the services being provided by such entities).
Each of the issues discussed supra in Part II (Need for Change) fall into one or more of
these categories.
While the current regulations state that Title X projects must not provide abortion
as a method of family planning, they do not provide sufficient guidance to ensure that
Title X projects comply with section 1008 by not encouraging or promoting abortion as a
method of family planning. Limiting section 1008’s prohibition to only “direct”
facilitation of abortion is not consistent with the best reading of that provision, which was
intended to ensure that Title X funds are not used to encourage or promote abortion in
any way. For example, the current regulations:
⦁ Mandate that providers provide counseling on and referral for abortion, if requested
by the client;
⦁ Permit shared locations, facilities, personnel, file systems, phone numbers, and
websites between Title X clinics and abortion clinics, creating confusion regarding the
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scope of Title X services and whether the Federal government is funding abortion
services; and
⦁ Permit a fungibility of assets that can be used to build infrastructure for abortion
services, including physical space, health information technology systems, including
electronic health records, bulk purchasing of contraceptives and other clinic supplies,
clinical training for staff, and community recruitment.
The lack of clear operational guidance on the abortion restriction in section 1008
has created confusion as to what activities are proscribed by section 1008. With abortions
increasingly performed at nonspecialized clinics primarily serving contraceptive and
family planning clients, it is critical that the Department ensure that Federal funds are not
directly or indirectly supporting, encouraging, or promoting abortion as a method of
family planning and that there is a clear demarcation between Title X funded services and
abortion-related services for which Title X funds cannot be used.
The current regulations suffer from additional deficiencies. They are inconsistent
with the conscience protections embodied in the Church, Coats-Snowe, and Weldon
Amendments; do not address the statutory requirement that Title X projects encourage
family participation in minors’ decisions to seek family planning services; do not
expressly address the obligation of Title X grantees and subrecipients to comply with
State reporting or notification requirements; and do not expressly prohibit the use of Title
X funds to encourage, promote, or advocate for abortion, to support any legislative
proposal that encourages abortion, or to support or oppose any candidate for public
office. In addition, the current regulations do not require Title X providers to either offer
comprehensive primary health services onsite or have a robust referral linkage with
83
primary health providers who are in close physical proximity to the Title X site. And the
current regulations fail to require grantees to provide the Department sufficient
information about the subrecipients with which they (or their subrecipients) contract and
any referral agencies or other partners to whom Title X funds may flow, thus precluding
OPA from exercising appropriate oversight of the activities of its program and project
subrecipients.
This proposed rule addresses each of the foregoing problems. First, to assist the
Department in ensuring compliance with, and enforcement of, the section 1008
prohibition, the proposed rule would prohibit family planning projects from using Title X
funds to provide or present abortion as a method of family planning; require assurances
of compliance; eliminate the requirement that Title X projects provide abortion
counseling and referral; prohibit Title X projects from performing, promoting, referring
for, or supporting, abortion as a method of family planning; require physical and financial
separation of Title X activities from those which are prohibited under section 1008;
prohibit certain activities that encourage, promote, or advocate for abortion; and provide
clarification on the appropriate use of funds in regard to the building of infrastructure.
To assist the Department in ensuring compliance with, and enforcement of,
appropriations provisos and riders addressing the Title X program, the proposed rule
would reiterate the voluntary, non-coercive nature of Title X services; require Title X
facilities to encourage family participation in a minor’s decision to seek family planning
services; explicitly prohibit the use of Title X funds for any activity that in any way tends
to promote public support or opposition to any legislative proposal or candidate for
office; incorporate the encouragement of family participation into the regulations; clarify
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the affirmative duty of projects to comply with State and local laws requiring notification
and reporting of criminal sexual exploitation; clarify that confidentiality of information
may not be used as a rationale for noncompliance with such notification or reporting
laws; and require assurances of compliance and maintenance of records.
To assist the Department in ensuring compliance with, and enforcement of,
conscience protections embodied in the Church, Coats-Snowe, and Weldon Amendments,
the proposed rule would eliminate the requirement that Title X projects provide abortion
counseling and referral; prohibit Title X projects from performing, promoting, referring
for, or supporting, abortion as a method of family planning; and clarify that single-
method service sites are permissible as components of a Title X family planning project,
as long as the overall project provides a broad range of acceptable and effective family
planning methods and services.
The Department believes that these proposed changes would ensure fidelity to the
statutory requirements and purposes of the Title X program, the appropriations provisos
and riders addressing the Title X program, and obligations and requirements established
under other Federal law. They would do so by aligning the current regulations with these
statutory provisions and providing the Department with the oversight tools necessary to
ensure compliance.
Second, to ensure that the Title X program places an adequate emphasis on
holistic family planning services that recognize the need for linkages with comprehensive
primary health care providers, the proposed rule would clarify the definition of family
planning; require the referral of pregnant patients for appropriate prenatal and/or social
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services; require the provision of comprehensive primary health services onsite or
through a robust referral linkage; and update the application review criteria.
The Department expects that these proposed changes would ensure that the Title
X program takes a holistic approach to family planning through the inclusion of referral
to prenatal care and social services for pregnant clients and requiring either
comprehensive primary health services onsite or through a robust referral linkage.
Third, to improve transparency regarding the provision of services, the proposed
rule would require additional information from applicants and grantees regarding
subrecipients, referral agencies, and community partners; require a clear explanation of
how grantees would ensure adequate oversight and accountability for compliance and
quality outcomes among subrecipients and those who serve as referrals for ancillary or
core services; and require each project supported under Title X to fully account for, and
justify, charges against the Title X grant. The Department anticipates that these proposed
changes will provide the information necessary to ensure, and determine compliance with
the statutory provisions on, program integrity, and the legal and ethical usage of taxpayer
dollars.
Title X grantees and subrecipients must comply with the Federal laws that are the
subject of this proposed rulemaking. In addition to conducting outreach and providing
technical assistance, OPA would have the authority to initiate compliance reviews and
take appropriate action to assure compliance with the provisions in this proposed rule.
2. Affected Entities
This proposed rule would affect the operations of entities who may receive Title
X grants or be subrecpients of such entities at some point in time. According to the 2016
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Family Planning Annual Report (FPAR), there were 91 Title X grantees and 1,117 Title
X subrecipients in 2016. These entities operated at 3,898 service sites, and provided
services to 4,007,552 people. For purposes of this analysis, we assume that these numbers
will remain the same across time. Title X services were delivered by 3,550 clinical
services provider FTEs, which include 780 physician FTEs, 258 registered nurse FTEs,
and 2,512 combined FTEs from physician’s assistants (PAs), nurse practitioners (NPs),
and certified nurse midwives (CNMs). These FTEs are associated with 1,403 Title X
family planning encounters per FTE, for 5.0 million total Title X family planning
encounters across these providers in 2016. Title X services are also delivered by other
types of service providers, who were involved with 1.7 million Title X family planning
encounters in 2016. Providers in these categories include registered nurses, public health
nurses, licensed vocational or licensed practical nurses, certified nurse assistants, health
educators, social workers, and clinic aides. To estimate the number of FTEs in these
categories, we assume that there are 1,403 encounters per FTE for individuals in these
categories, which implies approximately 1,219 FTEs in this category in 2016. To convert
FTEs reported in Family Planning Annual Report (FPAR) to the number of individuals in
these categories, we assume that each individual works an average of between 0.5 FTEs
and 1.0 FTEs delivering Title X services, with 0.75 FTEs as our central estimate,
uniformly across occupation categories. This implies that there are approximately 4,733
clinical service providers and 1,625 other service providers associated with the provision
of Title X-funded family planning services. We use these estimates as our estimate of
service providers affected by this rule.
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We estimate the hourly wages of individuals affected by this proposed rule using
information on hourly wages in the May 2016 National Occupational Employment and
Wage Estimates provided by the U.S. Bureau of Labor Statistics60 and salaries from the
U.S. Office of Personal Management.61 We use the salary of registered nurses as a proxy
for “other clinical service providers” and “other types of service providers” described
above. In FPAR, PAs, NPs, and CNMs are not distinguished. Since wages in these three
categories are very similar, we use the average wage across this group when discussing
impacts affecting the group. We use the wages of Medical and Health Services Managers
as a proxy for management staff, and the wages of Lawyers as a proxy for legal staff
throughout this analysis. To value the time of potential Title X service recipients, we take
the average wage across all occupations in the U.S. We assume that the federal
employees affected by the proposed changes to the Title X regulation are Step 5 within
their GS-level and earn locality pay for the District of Columbia, Baltimore, and Northern
Virginia. We divide annual salaries by 2,087 hours to derive hourly wages. We assume
that the total dollar value of labor, which includes wages, benefits, and overhead, is equal
to 200 percent of the wage rate. Estimated hourly rates for all relevant categories are
included below.
Throughout, estimates are presented in 2016 dollars. When present value and
annualized values are presented, they are discounted relative to year 2016. Finally, we
estimate impacts over five years starting in 2019.
60
Bureau of Labor Statistics, Occupational Employment and Wage Statistics (May 2016),
https://www.bls.gov/oes/2016/may/oes_nat.htm.
61
Office of Personnel Management, Salary Table 2016-DCB (Jan. 2016), https://www.opm.gov/policy-
data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2016/DCB.pdf.
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Table 2. Hourly Wages
Physician $101.04
Physician Assistant $49.08
Nurse Practitioner $50.30
Certified Nurse Midwife $49.23
Registered Nurse $34.70
Medical and Health Services Managers $52.58
Lawyers $67.25
Federal employees in the District of Columbia, Baltimore, and Northern
Virginia (2016)
GS-13 Step 5 $50.04
GS-14 Step 5 $59.13
GS-15 Step 5 $69.56
3. Estimated Costs:
a. Learning the Rule’s Requirements
In order to comply with the regulatory changes proposed in this proposed rule,
affected entities would first need to learn the rule’s requirements, review their policies in
the context of these new requirements, and determine how to respond. Affected entities
here would include not only existing grantees and subrecipients, but also potential
grantees and subrecipients. Consistent with our view that this proposed rule would
increase competition for Title X funding, we estimate that potential grantees and
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subrecipients range between 100% and 300% of their 2016 values, with a central estimate
of 200%. This implies 182 potential grantees and 2,234 potential subrecipients. We
estimate that learning the rule’s requirements and determining how to respond would
require an average of 20 hours for potential grantees and an average of 10 hours for
potential subrecipients, divided evenly between managers and lawyers, in the first year
following publication of the final rule. As a result, using wage information provided in
Table 2, this implies costs of $3.11 million in the first year following publication of a
final rule in this rulemaking.
b. Training
Individuals involved with delivering family planning services would also need to
receive training on the requirements of the proposed rule. To convert FTEs reported in
FPAR to the number of individuals that would receive training, we assume that each
individual works an average of between 0.5 FTEs and 1.0 FTEs delivering Title X
services, with 0.75 FTEs as our central estimate. This implies that there are
approximately 4,733 clinical service providers and 1,625 other service providers who
would need training in order to ensure compliance with these regulations when finalized.
We estimate that these individuals would require an average of 4 hours of training in the
first year following publication of this rule. In subsequent years, we assume that this new
information would be incorporated into existing training requirements, resulting in no
incremental burden. As a result, using wage information provided in Table 2, this would
imply costs of $2.71 million in the first year following publication of a final rule in this
rulemaking.
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In addition, training materials would need to be updated to reflect changes made
by this rulemaking. Training materials for Title X providers are currently developed by
contract. We estimate that these updates would cost approximately $200,000. In addition,
changes to training materials would require interaction with OPA employees in order to
ensure that the materials are suitable for Title X providers. We estimate that this would
require half of an FTE at the GS-13 level and half of an FTE at the GS-14 level. We
estimate that all of these costs would be incurred in the first year following publication of
the final rule. As a result, using wage information provided in Table 2, this would imply
costs of $0.43 million in the first year following publication of a final rule in this
rulemaking.
c. Assurance Submissions
Title X grantees and subrecipients would face new assurance requirements
because of this proposed rule. We estimate that these new requirements would require a
lawyer to spend an average of 3 hours reviewing the assurances, 3 hours reviewing
organizational policies and procedures, or to take other actions to assess compliance, and
a medical and health services manager to spend 2 hours total for the same tasks the first
year following publication of the final rule at each grantee and subrecipient. In
subsequent years, we estimate that these new requirements would require a lawyer to
spend an average of 1 hour reviewing the assurances, 3 hours reviewing organizational
policies and procedures, or to take other actions to assess compliance, and a medical and
health services manager to spend 2 hours total for the same tasks at each grantee and
subrecipient. As a result, using wage information provided in Table 2, this would imply
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costs of $1.2 million in the first year and $0.9 million in subsequent years following
publication of a final rule in this rulemaking.
d. Documentation of Compliance
Title X grantees and subrecipients would need to document their compliance with
new requirements because of this proposed rule. First, Title X grantees are required to
encourage minors to involve family in their decisions to seek family planning services.
Actions taken to satisfy this requirement must be documented in a minor’s medical
record. We estimate that each occurence would require a physician assistant to spend an
average of 2 minutes to make appropriate documentation in a minor’s medical records.
Approximately 20% (800,000) of the 4 million Title X clients are adolescents. We
estimate that complying with the requirement to encourage family participation will
result in 75% (600,000) of adolescent patients’ medical records requiring appropriate
documentation. As a result, using wage information provided in Table 2, this would
imply costs of $2.0 million in the each year following publication of a final rule in this
rulemaking.
Second, grantees must generate reports with information related to subrecipients,
referral agencies and individuals involved in the grantee’s Title X project. We estimate
that these new requirements would require a health services manager to spend an average
of 4 hours in each year following publication of the final rule at each grantee and
subrecipient. As a result, using wage information provided in Table 2, this would imply
costs of $0.3 million in each years following publication of a final rule in this
rulemaking.
e. Monitoring and Enforcement
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This proposed rule would result in additional monitoring of Title X grantees and
subrecipients in order to ensure compliance with new regulatory and existing statutory
requirements. We estimate that addressing additional monitoring and enforcement
activities would require management staff for each grantee to spend an average of an
additional 40 hours each year, and would require an average of an additional 10 hours for
each Title X service provider each year. Finally, additional monitoring and enforcement
require additional time spent by Federal staff. We estimate this would require 3 FTEs at
the GS-13 level, 2 FTEs at the GS-14 level, and 2 FTEs at the GS-15 level. As a result,
using wage information provided in Table 2, this would imply costs of $8.53 million
every year following publication of a final rule in this rulemaking.
f. Physical Separation
As a result of this proposed rule, Title X providers would be required to provide
Title X services at facilities that physically separate from locations at which abortion as a
method of family planning is provided. A Congressional Research Service62 report
estimates that 10% of clinics that receive Title X funding offer abortion as a method of
family planning separately from their Title X-funded activities.. In addition, Title X
providers may share resources with unaffiliated entities that offer abortion as a method of
family planning. As a result, we estimate that between 10% and 30% of service sites,
with a central estimate of 20%, would need to be evaluated to determine whether they
comply with the proposed physical separation requirements. We estimate that this
evaluation would require an average of an additional five hours by management staff at
62
Napili, A., Title X (Public Health Service Act) Family Planning Program, Congressional Research
Service Report RL33644 (Aug. 31, 2017).
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each of these affected service sites in the first year following publication of a final rule.
Similarly, we estimate that this evaluation would affect between 10% and 30% of
grantees, with a central estimate of 20%. We estimate that this would require an average
of an additional forty hours, divided evenly between lawyers and management staff, at
each affected grantee, in the first year following publication of a final rule. We estimate
that these evaluations would determine that between 10% and 20% of service sites, with a
central estimate of 15%, do not comply with physical separation requirements. At each of
these service sites, we estimate that an average of between $10,000 and $30,000, with a
central estimate of $20,000, would be incurred to come into compliance with physical
separation requirements in the first year following publication of a final rule in this
rulemaking. As a result, using wage information provided in Table 2, this would imply
costs of $24.38 million in the first year following publication of a final rule.
g. Encouraging Parental Involvement in Family Planning Services
Title X providers are already required by the statute to encourage minors to
involve their parents in family planning services. However, it is currently unclear whether
this requirement is being satisfied by Title X providers. As a result, this proposed rule
would require that actions be taken to satisfy this requirement and that such actions be
documented in a minor’s medical record. We believe that this will result in improved
compliance with the statutory requirement that minors be encouraged to involve their
parents in family planning services. As noted previously, we estimate that complying
with the requirement to document the encouragement of family participation will result in
600,000 adolescent patients’ medical records requiring documentation as a result of these
requirements each year. We estimate that an additional 0-50% of these adolescents, with
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a central estimate of 25%, would receive additional encouragement to involve parents as
a result of a final rule in this rulemaking proceeding each year. We estimate that this
would require an average of an additional ten minutes spent by a registered nurse and ten
minutes spent by the service recipient in each case. These impacts would occur in each
year following publication of a final rule in this rulemaking. As a result, using wage
information provided in Table 2, this would imply costs of $2.93 million in each year
following publication of a final rule.
4. Estimated Benefits:
This proposed rule is expected to offer benefits to taxpayers and stakeholders who
want assurance that their tax dollars are being used in compliance with the requirements
of the Title X program. It is also expected to increase the number of entities interested in
participating in Title X as grantees or subrecipient service providers and, thereby, to
increase patient access to family planning services focused on optimal health outcomes
for every Title X client. Third, because of the clarifying language, as well as the new
provisions within this proposed rule, we also expect the quality of service to improve.
Finally, the proposed rule would clarify the role of the Title X program within
communities across the nation, expand and diversify the field of medical professionals
who serve individuals and families, and build a better appreciation for the important
services offered as a result.
a. Upholding and Preserving the Purpose and Goals of the Title X Program
As discussed in the preamble, the statutory prohibition on the use of Title X funds
in programs/projects where abortion is a method of family planning has been in existence
as long as the program, and has been reiterated through annual appropriations provisos.
95
This proposed rule is expected to provide the Department with tools to ensure compliance
with those statutory requirements. It is also expected to increase transparency and
assurances that taxpayer dollars are being used as Congress intended. The Title X
program, too, would benefit, as the requirement of physical and financial separation and
the prohibition on infrastructure building for non-Title X purposes would ensure greater
accountability for the use of Federal funds, mitigate confusion about what services the
Federal government supports and funds, and increase the amount of Title X funds that are
used to deliver family planning services.
b. Patient/Provider Benefits and Protections
The Department expects that the proposed rule would have additional benefits for
patients and providers. Benefits for patients are at least twofold. First, as noted above, the
new regulation would require Title X service providers to offer either comprehensive
primary health services onsite or have a robust referral linkage with primary health
providers who are in close physical proximity to the Title X site. This would promote
seamless care and services for patients while expanding the breadth of services available
within the states, territories and throughout the regions.
Second, the proposed regulation would protect certain patients from further
victimization. It would do so by requiring Title X grantees and subgrantees to comply
with all State and local laws requiring notification or reporting of child abuse, child
molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking;
to develop a plan for such compliance and provide adequate training for all personnel on
the subject; and to maintain records identifying the age of any minor clients served, the
age of their sexual partner(s) where required by law, and the reports or notifications made
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to appropriate State or local law enforcement or other authorities, in accordance with
such laws. These provisions would protect patients, especially minor children, from
further victimization, and promote the identification and bringing to justice of those who
would prey on women and children.
For providers, the proposed regulation is expected to create benefits through
respect for conscience. It would do so by better aligning the Title X regulations with the
statutory prohibitions on discrimination against health care entities, including individual
health care providers, who refuse to participate in abortion–related activity such as
counseling and referrals. Potential grantees, and subrecipients that refuse to provide
abortion counseling and referrals may now be eligible and interested in applying to
provide family planning services under the current Title X regulations. And the
expansion of provider and family planning options would have salutary benefits for
patients, including for patients who seek providers who share their religious or moral
convictions.
As the Department has stated with regard to other conscience protection actions,
open communication in the doctor-patient relationship would foster better over-all care
for patients. While the benefit of open and honest communication between a patient and
her doctor is difficult to quantify, one study showed that even “the quality of
communication [between the physician and patient] affects outcomes . . . [and] influences
how often, and if at all, a patient would return to that same physician.”63 Facilitating open
communication between providers and their patients helps to eliminate barriers to care,
63
Fallon E. Chipidza, F. E. et al., Impact of the Doctor-Patient Relationship, The Primary Care Companion
for CNS Disorders 17(5) (Oct. 22, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732308.
97
particularly for minorities. Because positions of conscience are often grounded in
religious influence, “[d]enying the aspect of spirituality and religion for some patients
can act as a barrier. These influences can greatly affect the well-being of people. These
influences were reported to be an essential element in the lives of certain migrant women
which enabled them to face life with a sense of equality.”64 It is important for patients
seeking care to feel assured that their faith, and the principles of conscience grounded in
their faith, would be honored, especially in the area of family planning. This would
ensure that patients with such religious or moral convictions feel they are being treated
fairly and that their religious or moral convictions are respected.65
C. Analysis of Regulatory Alternatives
The Department carefully considered the alternatives to this proposed rule, but
concluded that none would adequately address the two categories of problems it seeks to
address: (1) insufficient compliance with the statutory requirements and the purpose and
goals of the Title X program (especially those related to section 1008), the appropriations
provisos and riders addressing the Title X program, and other obligations and
requirements established under other Federal law; and (2) lack of transparency regarding
the provision of services.
First, the Department considered maintaining the status quo and utilizing
programmatic guidance and funding opportunity announcements (FOAs, also known as
notices of funding opportunities) to address the problems described above. Such actions,
64
Scheppers, E. et al., Potential Barriers to the Use of Health Services Among Ethnic Minorities: A
Review, Family Practice (23):325, 343 (June 1, 2006),
https://academic.oup.com/fampra/article/23/3/325/475515.
65
Id.
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however, would be incompatible with part 59 as it currently exists. Specifically, Title X
providers would still be required to provide counseling on, and referral for, abortion upon
request, a requirement inconsistent with section 1008 that could be discouraging to, and
disqualify, potential grantees and subrecipients that refuse to counsel on, or provide
referrals for, abortion. The maintenance of this requirement, as noted above, potentially
violates the Coats-Snowe Amendment and the Weldon Amendment. Moreover, there
would be no mechanisms by which the Department would be able to verify whether
grantees and their subrecipients are complying with the statutory program integrity,
education, and reporting requirements. In addition, the Department would still be using
application review criteria that the Department now believes fail to ensure that applicants
comply with the statutory requirements of the Title X program. As detailed earlier in the
preamble, application review criteria must serve as a meaningful instrument to assess the
quality of the applicant and the application. The current application review criteria lack
rigor, making it possible for less qualified applicants to garner high scores and affording
the Department little help in selecting strong Title X grantees. While the Department has
discretion under the current criteria to issue FOAs that add to criteria in the regulation, as
past FOAs have done, and the Department could thus seek to strengthen the selection
criteria through FOA requirements, such an approach is inadequate to ensure that
appropriate criteria are fully set forth, required by regulation, and give the public notice
of the long term commitment of the program.
HHS considered a variety of options to ensure that it is clear to grantees, the
general public, and patients who depend upon Title X services, that Title X programs do
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not fund, support, or promote abortion as a method of family planning. Specifically, we
considered:
(1) Maintaining the status quo, where only line-item financial separation from
activities that treat abortion as a method of family planning is required. Currently Title X
costs must be pro-rated from abortion-related activities. There is a need for greater
financial oversight and accountability than is possible under the current regulations, in
order to ensure that Title X funds are used only for permissible Title X services. And the
current financial accounting separation leaves too much ambiguity surrounding abortion
activities that may be a part of the overall services of the organization or facility,
although not a part of Title X-funded family planning services.
(2) Requiring signage, brochures or separate staff and examination rooms within
the same physical space to delineate a separation between Title X and abortion-related
services. The Department considered that this less restrictive option might serve the same
goal as physical separation in erasing, or mitigating to some extent, the current confusion
between Title X and abortion-related services. The Department determined that this less
restrictive option might serve the same goal in erasing the current confusion between
Title X and abortion-related services. But the Department determined that a shared
reception area with materials available on both Title X family planning services and
abortion-related services would continue the confusion, rather than mitigate it. Signage is
often not read, and it would be likely that the segregation of staff/staff responsibilities
within the same reception area would not provide sufficient distinction to end confusion.
If the same physical space provides both Title X and abortion-related services, signs and
separate receptionists may only partially mitigate, but not eliminate, the public perception
100
and confusion. Different examination rooms would likely have little impact because
patients would likely be unaware that the purpose of a suite of examination rooms differs
by funding stream, if the entrance and reception area is shared in common. The optics
and practical operation of two distinct services within a single collocated space are
difficult, if not impossible to overcome.
Thus, for these reasons and the reasons for our decision to propose both physical
and financial separation, we preliminary determine that both of these options would be
insufficient to ensure statutory compliance and clarity regarding such compliance. The
Department seeks public comment on these alternatives.
The Department seeks comment on whether additional policies or requirements,
beyond those proposed herein, should be imposed to ensure compliance. These include
expanding the requirement that referral agencies that do not receive Title X funds but
nevertheless provide information, counseling, or services to Title X clients be subject to
the same reporting and compliance requirements as do grantees and subrecipients; and
requiring organizational separation in addition to physical and financial separation.
The Department invites comment on both its proposed approach and other
approaches to assure compliance with the statutory requirements, along with the
provision of holistic family planning services, age appropriate education and services for
adolescents, and other services that promote healthy outcomes and provide transparency
regarding the provision of services.
D. Executive Order 13771
Executive Order 13771 (January 30, 2017) requires that the costs associated with
significant new regulations “to the extent permitted by law, be offset by the elimination
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of existing costs associated with at least two prior regulations.” This proposed rule, if
finalized as proposed, is expected to be an Executive Order 13771 regulatory action. The
Department estimates that this rule generates $13.6 million in annualized costs at a 7%
discount rate, discounted relative to fiscal year 2016, over a perpetual time horizon.
E. Regulatory Flexibility Analysis
As discussed above, the RFA requires agencies that issue a regulation to analyze
options for regulatory relief of small entities if a proposed rule has a significant impact on
a substantial number of small entities. HHS considers a rule to have a significant
economic impact on a substantial number of small entities if at least 5 percent of small
entities experience an impact of more than 3 percent of revenue.
We calculate the costs of the proposed changes per service site over 2019-2023.
The estimated average annualized cost of the rule per service site is approximately $5,423
using a 3 percent discount rate. We note that this figure includes all costs, and that
relatively large entities are likely to experience proportionally higher costs. The U.S.
Small Business Administration establishes size standards that define a small entity.
According to these standards, family planning centers with revenues below $11.0 million
are considered small entities. Since the estimated costs of the proposed rule would be a
small fraction of the standard by which a family planning center entity is considered a
small entity, the Department anticipates that the proposed rule would not have a
significant economic impact on a substantial number of small entities.
F. Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations Act of
1999, Pub. L. 105-277, sec. 654, 112 Stat. 2681 (1998), requires Federal departments and
102
agencies to determine whether a proposed policy or regulation could affect family well-
being.66
Agencies must assess whether the proposed regulatory action: (1) Impacts the
stability or safety of the family, particularly in terms of marital commitment; (2) impacts
the authority of parents in the education, nurture, and supervision of their children; (3)
helps the family perform its functions; (4) affects disposable income or poverty of
families and children; (5) if the regulatory action financially impacts families, are
justified; (6) may be carried out by State or local government or by the family; and (7)
establishes a policy concerning the relationship between the behavior and personal
responsibility of youth and the norms of society.67 If the determination is affirmative,
then the Department or agency must prepare an impact assessment to address criteria
specified in the law.
The Department believes the action taken in this proposed rule cannot be carried
out by State or local government or by the family because the rule pertains to the
enforcement of certain Federal laws and the administration of a Federal program.
The Secretary proposes to certify that this proposed rule has been assessed in
accordance with Section 654 of the Treasury and General Government Appropriations
Act of 1999, Pub. L. 105-277, sec. 654, 112 Stat. 2681 (1998), and would not negatively
affect family well-being.
66
This section discusses the assessment required in Executive Order 12606, The Family, which was
revoked on April 21, 1997. Office of Management and Budget, Memorandum from Jacob Lew, Dir., To
Heads of Executive Departments, Agencies, & Independent Establishments Assessment of Federal
Regulations and Policies on Families (Jan. 26, 1999), .https://www.fws.gov/policy/library/rglew.pdf.
67
Treasury and General Government Appropriations Act, 1999, Pub. L. 105-277, sec. 654, 112 Stat. 2681,
2681-528- 2681–530 (1998).
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G. Paperwork Reduction Act
This proposed rule contains information collection requirements (ICRs) that are
subject to review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995. A description of these provisions is given in the following
paragraphs with an estimate of the annual burden, summarized in Table 3. To fairly
evaluate whether an information collection should be approved by OMB, section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) requires that we solicit
comment on the following issues:
⦁ The need for the information collection and its usefulness in carrying out the
proper functions of our agency.
⦁ The accuracy of our estimate of the information collection burden.
⦁ The quality, utility, and clarity of the information to be collected.
⦁ Recommendations to minimize the information collection burden on the
affected public, including automated collection techniques.
We are soliciting public comment on each of the required issues under section
3506(c)(2)(A) of the PRA. The collections of information required by the proposed rule
relate to § 59.2 (Definitions), § 59.5 (What requirements must be met by a family
planning project?), § 59.7 (What criteria would the Department of Health and Human
Services use to decide which family planning services projects to fund and in what
amounts?), § 59.13 (Standards of compliance with prohibition on abortion), § 59.17
(Compliance with reporting requirements), and § 59.18 (Appropriate use of funds).
Proposed § 59.2 would apply to situations where an unemancipated minor wishes
to receive services on a confidential basis and be considered on the basis of her/his own
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resources, as would proposed § 59.5(a)(14). In such cases, the Title X provider would be
required to document in the minor’s medical records the specific actions taken by the
provider to encourage the minor to involve her/his family (including her/his parents or
guardian) in her/his decision to seek family planning services. This documentation
requirement would not apply if the Title X provider (1) believes that the minor is a victim
of child abuse or incest and (2) has, consistent with applicable State or local law, reported
the situation to the relevant authorities. The reporting requirement must be documented in
the medical record.
Proposed § 59.5 would require Title X providers to report, in grant applications
and in all required reports, information regarding subrecipients and referral agencies and
individuals, including a detailed description of the extent of collaboration and a clear
explanation of how the grantee would ensure adequate oversight and accountability; and
to maintain records with respect to minors on the specific actions taken to encourage
family participation (or the reason why such family participation was not encouraged).
Proposed § 59.7 would require Title X grant applicants to describe, within their
applications, their affirmative compliance with each provision of the regulations
governing the Title X program.
Proposed § 59.13 would require Title X grantees to provide assurance satisfactory
to the Secretary that, as a Title X grantee, it does not provide abortion and does not
include abortion as a method of family planning. This assurance would include, at a
minimum, representations (supported by documentary evidence where the Secretary
requests it) as to compliance with § 59.13 and each of the requirements in §§ 59.14
through 59.16.
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Proposed § 59.17 would require Title X grantees to provide appropriate
documentation or other assurance satisfactory to the Secretary that it has in place and has
implemented a plan to comply with all State and local laws requiring notification or
reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner
violence, and human trafficking. It would also require Title X grantees to maintain
records to demonstrate compliance with the requirements of § 59.17, and make
continuation of funding for Title X services contingent upon demonstrating to the
Secretary that the criteria have been met.
Lastly, proposed § 59.18 would require Title X grantees to give a detailed
accounting of use related to grant dollars, both in their applications for funding, and
within any annually required reporting, and to fully account for, and justify, charges
against the Title X grant.
Burden of Response: The Department is committed to leveraging existing grant,
contract, annual reporting, and other Departmental forms where possible, rather than
creating additional, separate forms for recipients to sign. We anticipate two separate
burdens of response: (1) assurance of compliance; and (2) documentation of compliance.
The burden for the assurance of compliance is the cost of grantee and/or subrecipient
staff time to (a) review the assurance language as well as the underlying language related
to stated requirements; (b) to review grantee and/or subrecipient policies and procedures
or to take other actions to assess grantee and/or subrecipient compliance with the
requirements to which the grantee and/or subrecipient is required to assure compliance.
The labor cost would include a lawyer spending an average of 3 hours reviewing
all assurances and a medical and health service manager spending an average of one hour
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reviewing and signing the assurances at each grantee and subrecipient. We estimate the
number of grantees and subrecipients at 1,208, based on 2016 number of Title X grantees
and subrecipients, as represented in Title X FPAR data. The mean hourly wage (not
including benefits and overhead) for these occupations is $67.25 per hour for the lawyer
and $52.58 for the medical and health service manager, as noted in the table above. The
labor cost is $307,000 in the first year (($67.25 × 3 + $52.58 × 1) × 1,208 grantees and
subrecipients). We estimate that the cost, in subsequent years, would be $145,000, which
would represent an annual allotment of one hour for the lawyer and one hour for the
medical and health service manager (($67.25 × 1 + $52.58 × 1) × 1,208 grantees and
subrecipients).
The Department estimates that all recipients and subrecipients will review their
organizational policies and procedures or take other actions to self-assess compliance
with applicable Title X requirements each year, spending an average of 4 hours doing so.
The labor cost is a function of a lawyer spending an average of 3 hours and a medical and
health service manager spending an average of one hour. The labor cost for self-assessing
compliance, such as reviewing policies and procedures, is a total of $307,000 each year
(($67.25 × 3 + $52.58 × 1) × 1,208 grantees and subrecipients).
The burden for the documentation of compliance is the cost of grantee and/or
subrecipient staff time to (a) document in a minor’s medical records actions taken to
encourage the minor to involve parents in family planning services and (b) complete
reports regarding information related to subrecipients, referral agencies and individuals
involved in the grantee’s Title X project. We assume that a physician assistant would be
used to document such compliance. The mean hourly wage (not including benefits and
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overhead) for this occupation is $49.08 per hour. The labor cost would require spending
an average of 10 minutes to make appropriate documentation in a minor’s medical
records. Approximately 20% (800,000) of the 4 million Title X clients are adolescents.
We estimate that complying with the requirement to encourage family participation will
result in 75% (600,000) of adolescent patients’ medical records requiring appropriate
documentation. The labor cost will be $982,000 each year ($49.08 per hour × 2 minutes x
600,000 adolescents).
The labor cost would also include a medical and health services manager
spending an average of four hours each year to complete reports regarding information
related to subrecipients, and referral agencies and individuals involved in the grantee’s
Title X project at each grantee and subrecipient. The labor cost will be $254,000 each
year ($52.58 per hour × 4 hours x 1,208 grantees and subrecipients).
Table #3 - Proposed Annual Recordkeeping and Reporting Requirements or

Burden of Response in Year One/Subsequent Years following Publication of
the Final Rule
Regulation OMB Respondents Hourly rate Burden Total annual Labor cost of reporting
Burden control Responses ($) per burden (hours) ($)
No. response
(hours)
Assurance of 1,208/1,208 63.58/62.36 8/6 9,664/7,248 614,000/452,000
Compliance
Documentation 1,208/1,208 52.58/52.58 2/2 2,416/2,416 254,000/254,000
of Compliance
Documentation 600,000/600,000 49.08/49.08 .03/.03 100,000/100,000 982,000/982,000
on Minor’s
Medical
Records
Total Cost 5,813,000/5,424,000
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The Department asks for public comment on the proposed information collection
including what additional benefits may be cited as a result of this proposed rule.
Comments regarding the collection of information proposed in this proposed rule
must refer to the proposed rule by name and docket number, and must be submitted to
both OMB and the Docket Management Facility where indicated under ADDRESSES by
the date specified under DATES.
When it issues a final rule, the Department plans to publish in the Federal
Register the control numbers assigned by the Office of Management and Budget (OMB).
Publication of the control numbers notifies the public that OMB has approved the final
rule's information collection requirements under the Paperwork Reduction Act of 1995.
List of Subjects in 42 CFR Part 59
Birth control, Family planning, Abortion, Grant programs.
For the reasons set forth in the preamble, the Department of Health and Human
Services proposes to revise 42 CFR Chapter I, Subchapter D, part 59, as set forth below:
PART 59—GRANTS FOR FAMILY PLANNING SERVICES
1. Revise the Contents of Subpart A to read as follows:
Subpart A—Project Grants for Family Planning Services
§ 59.1 To what programs do these regulations apply?
§ 59.2 Definitions.
§ 59.3 Who is eligible to apply for a family planning services grant?
§ 59.4 How does one apply for a family planning services grant?
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§ 59.5 What requirements must be met by a family planning project?
§ 59.6 What procedures apply to assure the suitability of informational and
educational material?
§ 59.7 What criteria will the Department of Health and Human Services use to
decide which family planning services projects to fund and in what amount?
§ 59.8 How is a grant awarded?
§ 59.9 For what purpose may grant funds be used?
§ 59.10 What other HHS regulations apply to grants under this subpart?
§ 59.11 Confidentiality.
§ 59.12 Additional conditions.
§ 59.13 Standards of compliance with prohibition on abortion.
§ 59.14 Prohibition on referral for abortion.
§ 59.15 Maintenance of program integrity.
§ 59.16 Prohibition on activities that encourage, promote or advocate for abortion.
§ 59.17 Compliance with reporting requirements.
§ 59.18 Appropriate use of funds.
§ 59.19 Transition provisions.
2. The authority citation is revised to read as follows:
Authority: 42 U.S.C. 300 through 300a-6.
3. Revise § 59.1 to read as follows:
§ 59.1 To what programs do these regulations apply?
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(a) The regulations of this subpart are applicable to the award of grants under
section 1001 of the Public Health Service Act (42 U.S.C. 300) to assist in the
establishment and operation of voluntary family planning projects. These projects shall
consist of the educational, comprehensive medical, and social services necessary to aid
individuals to determine freely the number and spacing of their children. Unless
otherwise specified, the requirements imposed by these regulations apply equally to
grantees and subrecipients, grantees shall require subrecipients (and the subrecipients of
subrecipients) to comply with the requirements contained in such regulations pursuant to
their written contracts with such subrecipients, and shall be required to ensure that their
subrecipients (and the subrecipients of subrecipients) comply with such requirements.
(b) Except for § 59.3, § 59.4, § 59.8, and § 59.10 of this subpart, the regulations
of this subpart are also applicable to the execution of contracts under section 1001 of the
Public Health Service Act (42 U.S.C. 300) to assist in the establishment and operation of
voluntary family planning projects, and will be applied in accordance with the applicable
statutes, procedures and regulations that generally govern Federal contracts. To this
extent, the use of the terms “grant,” “award,” “grantee” and “subrecipient” in applicable
regulations of this subpart will apply similarly to contracts, contractors and
subcontractors, and the use of the term “project” or “program” will also apply to a project
or program established by means of a contract.
4. Amend § 59.2 by:
a. Revising the definition of “low income family”; and
b. Adding, in alphabetical order, new definitions of “family planning”, “grantee”,
“program” and “project”, and “subrecipient”.
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The revisions and additions read as follows:
§ 59.2 Definitions.
As used in this subpart:
* * * * *
“Family planning” means the voluntary process of identifying goals and
developing a plan for the number and spacing of children and the means by which those
goals may be achieved. These means include a broad range of acceptable and effective
choices, which may range from choosing not to have sex to the use of other family
planning methods and services to limit or enhance the likelihood of conception (including
contraceptive methods and natural family planning or other fertility awareness-based
methods) and the management of infertility (including adoption). Family planning
services include preconceptional counseling, education, and general reproductive and
fertility health care to improve maternal and infant outcomes, and the health of women,
men, and adolescents who seek family planning services, and the prevention, diagnosis,
and treatment of infections and diseases which may threaten childbearing capability or
the health of the individual, sexual partners, and potential future children). Family
planning and family planning services are never coercive and are strictly voluntary.
Family planning does not include postconception care (including obstetric or prenatal
care) or abortion as a method of family planning. Family planning, as supported under
this subpart, should reduce the incidence of abortion.
“Grantee” means the entity that receives Federal financial assistance by means of
a grant, and assumes legal and financial responsibility and accountability for the awarded
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funds, for the performance of the activities approved for funding and for reporting
required information to the Office of Population Affairs.
“Low income family” means a family whose total income does not exceed 100
percent of the most recent Poverty Guidelines issued pursuant to 42 U.S.C. 9902(2).
“Low-income family” also includes members of families whose annual income exceeds
this amount, but who, as determined by the project director, are unable, for good reasons,
to pay for family planning services. For example:
(a) Unemancipated minors who wish to receive services on a confidential basis
must be considered on the basis of their own resources, provided that the Title X provider
has documented in the minor’s medical records the specific actions taken by the provider
to encourage the minor to involve her/his family (including her/his parents or guardian)
in her/his decision to seek family planning services, except that documentation of such
encouragement is not be required if the Title X provider has documented in the medical
record, (1) that it suspects the minor to be the victim of child abuse or incest and (2) that
it has, consistent with and if permitted or required by applicable State or local law,
reported the situation to the relevant authorities.
(b) With respect to contraceptive services, a woman can be considered from a
“low-income family” if she has health insurance coverage through an employer which
does not provide the contraceptive services sought by the woman because it has a
sincerely held religious or moral objection to providing such coverage.
* * * * *
“Program” and “project” are used interchangeably and mean a plan or sequence of
activities that fulfills the requirements elaborated in a Title X funding announcement and
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may be comprised of, and implemented by a single grantee or subrecipient(s), or a group
of partnering providers who, under a grantee or subrecipient, deliver comprehensive
family planning services that satisfy the requirements of the grant within a service area.
* * * * *
“Subrecipient” means any entity that provides family planning services with Title
X funds under a written agreement with a grantee or another subrecipient. These entities
may also be referred to as “delegates” or “contract agencies.”
5. Amend § 59.3 by:
a. Revising the heading.
b. Removing paragraph (b).
c. Removing the reference to (a).
The revisions read as follows:
§ 59.3 Who is eligible to apply for a family planning services grant?
Any public or nonprofit private entity in a State may apply for a grant under this subpart.
6. Amend § 59.5 by:
a. Revising paragraph (a)(1);
b. Revising paragraph (a)(5);
c. Removing paragraphs (a)(5)(i) and (a)(5)(ii);
d. Removing paragraph (a)(10)(i);
e. Redesignating paragraph (a)(10)(ii) as (a)(10);
f. Adding new paragraphs (a)(12), (a)(13), and (a)(14);
g. Revising paragraph (b)(1); and
h. Revising paragraph (b)(8).
114
The revisions read as follows:
§ 59.5 What requirements must be met by a family planning project?
(a) * * *
(1) Provide a broad range of acceptable and effective family planning methods
(including contraceptives, natural family planning and other fertility-awareness based
methods) and services (including infertility services, including adoption, and services for
adolescents). Such projects are not required to provide every acceptable and effective
family planning method or service. A participating entity may offer only a single method
or a limited number of methods of family planning as long as the entire project offers a
broad range of such family planning methods and services.
* * * * *
(5) Not provide, promote, refer for, support, or present abortion as a method of
family planning.
* * * * *
(12) In order to promote holistic health and provide seamless care, Title X service
providers should offer either comprehensive primary health services onsite or have a
robust referral linkage with primary health providers who are in close physical proximity
to the Title X site.
(13) Ensure transparency in the delivery of services by reporting the following
information in grant applications and all required reports:
(i) Subrecipients and referral agencies and individuals by name, location,
expertise and services provided or to be provided;
115
(ii) Detailed description of the extent of the collaboration with subrecipients,
referral agencies and individuals, as well as less formal partners within the community, in
order to demonstrate a seamless continuum of care for clients; and
(iii) Clear explanation of how the grantee will ensure adequate oversight and
accountability for quality and effectiveness of outcomes among subrecipients and those
who serve as referrals for ancillary or core services.
(14) Encourage family participation in the decision of minors to seek family
planning services and ensure that the records maintained with respect to each minor
document the specific actions taken to encourage such family participation (or the
specific reason why such family participation was not encouraged).
(b) * * *
(1) Provide for medical services related to family planning (including physician’s
consultation, examination prescription, and continuing supervision, laboratory
examination, contraceptive supplies) and necessary referral to other medical facilities
when medically indicated, consistent with § 59.14(a) of this Subpart, and provide for the
effective usage of contraceptive devices and practices.
* * * * *
(8) Except as provided in § 59.14(a) of this Subpart, provide for coordination and
use of referral arrangements with other providers of health care services, local health and
welfare departments, hospitals, voluntary agencies, and health services projects supported
by other federal programs.
* * * * *
116
7. Amend § 59.7 by
a. Redesignating paragraphs (b) and (c) as (d) and (e);
b. Adding new paragraphs (a), (b), and (c) as follows:
§ 59.7 What criteria will the Department of Health and Human Services use to
decide which family planning services projects to fund and in what amounts?
(a) Within the limits of funds available for these purposes, the Secretary may
award grants for the establishment and operation of those projects which will, in the
Department’s judgment, best promote the purposes of statutory provisions applicable to
the Title X program.
(b) Any grant applications that do not clearly address how the proposal will
satisfy the requirements of this regulation shall not proceed to the competitive review
process, but shall be deemed ineligible for funding. The Department will explicitly
summarize each provision of the regulation (or include the entire regulation) within the
Funding Announcement, and shall require each applicant to describe their plans for
affirmative compliance with each provision.
(c) If the proposal is deemed compliant with this regulation, then applicants will
be subject to criteria for selection within the competitive grant review process, including:
planning projects which shall offer a broad range of acceptable and effective family planning
methods and services (including natural family planning methods, infertility services, and
services for adolescents” (PHS Act Sec. 1001(a), 42 U.S.C. 300(a)), which meet all of the
statutory and regulatory requirements and restrictions, and where “none of the funds…shall
117
be used in programs where abortion is a method of family planning.” (PHS Act Sec.
1008, 42 U.S.C. 300a-6).
(2) The degree to which “the relative need of the applicant” (PHS Act Sec 1001(b),
42 U.S.C. 300(b)) is demonstrated in the proposal and the applicant shows capacity to “make
rapid and effective use” (PHS Act Sec. 1001(b), 42 U.S.C. 300(b)) of grant funds,
including and especially among a broad range of partners and diverse subrecipients and
referral individuals and organizations, and among non-traditional Title X partnering
organizations.
8. Revise § 59.11 to read as follows:
§ 59.11 Confidentiality.
All information as to personal facts and circumstances obtained by the project
staff about individuals receiving services must be held confidential and not be disclosed
without the individual’s documented consent, except as may be necessary to provide
services to the patient or as required by law, with appropriate safeguards for
confidentiality; concern with respect to the confidentiality of information, however, may
not be used as a rationale for noncompliance with laws requiring notification or reporting
118
of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence,
human trafficking, or similar reporting laws. Otherwise, information may be disclosed
only in summary, statistical, or other form which does not identify particular individuals.
9. Add new §§ 59.13 through 59.19, as follows:
§ 59.13 Standards of compliance with prohibition on abortion.
A project may not receive funds under this subpart unless it provides assurance
satisfactory to the Secretary that, as a Title X grantee, it does not provide abortion and
does not include abortion as a method of family planning. Such assurance must also
include, at a minimum, representations (supported by documentary evidence where the
Secretary requests it) as to compliance with this section and each of the requirements in
§§ 59.14 through 59.16. A project supported under this subpart must comply with such
requirements at all times during the project period.
§ 59.14 Prohibition on referral for abortion.
(a) A Title X project may not perform, promote, refer for, or support, abortion as
a method of family planning, nor take any other affirmative action to assist a patient to
secure such an abortion. If asked, a medical doctor may provide a list of licensed,
qualified, comprehensive health service providers (some, but not all, of which also
provide abortion, in addition to comprehensive prenatal care), but only if a woman who is
currently pregnant clearly states that she has already decided to have an abortion. This list
is only to be provided to a woman who, of her own accord, makes such a request. The list
shall not identify the providers who perform abortion as such. All other patients will be
provided, upon request, a list of licensed, qualified, comprehensive health service
119
providers (including providers of prenatal care) who do not provide abortion as a part of
their services.
(b) Because Title X funds are intended only for family planning, once a client
served by a Title X project is medically verified as pregnant, she must be referred for
appropriate prenatal and/or social services (such as prenatal care and delivery, infant care,
foster care, or adoption), and shall be given assistance with setting up a referral
appointment to optimize the health of the mother and unborn child. She must also be
provided with information necessary to protect her health and the health of the unborn
child until such a time as the referral appointment is kept. In cases in which emergency
care is required, the Title X project shall only be required to refer the client immediately
to an appropriate provider of emergency medical services.
(c) A Title X project may not use prenatal, social service, emergency medical, or
other referrals as an indirect means of encouraging or promoting abortion as a method of
family planning. Recognizing, however, the duty of a physician to promote patient safety,
a doctor may, if asked, provide a list of licensed, qualified, comprehensive health service
providers (some of which also provide abortion, in addition to comprehensive prenatal
care). Such information related to abortion is permitted only if a woman who is currently
pregnant clearly states that she has already decided to have an abortion.
(d) Nothing in this subpart shall be construed as prohibiting the provision of
information to a project client that is medically necessary to assess the risks and benefits
of different methods of contraception in the course of selecting a method, provided that
the provision of such information does not otherwise promote abortion as a method of
family planning.
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(e) Examples.
(1) A pregnant client of a Title X project requests prenatal care services, which
project personnel are qualified to provide. Because the provision of such services is
outside the scope of family planning supported by Title X, the client must be referred to
appropriate providers of prenatal care. Provision of prenatal services within the Title X
project is inconsistent with this part.
(2) A Title X project discovers an ectopic pregnancy in the course of conducting a
physical examination of a client. Referral arrangements for emergency medical care are
immediately provided. Such action complies with the requirements of paragraph (b) of
this section.
(3) After receiving comprehensive care at a Title X provider, a pregnant woman
decides to have an abortion, is concerned about her safety during the procedure, and asks
the Title X project to provide her with a referral to an abortion provider. The Title X
project tells her that it does not refer for abortion but provides her a list of licensed,
qualified health care professionals in the area (some of whom provide abortion as part of
their primary health care services). The list includes, among other licensed, qualified,
comprehensive health care providers, a local health care professional who provides
abortions in addition to comprehensive prenatal care. Inclusion of this provider/clinic on
the list is consistent with paragraph (a) of this section.
(4) A pregnant woman asks the Title X project to provide her with a list of
abortion providers in the area. The project tells her that it does not refer for abortion and
provides her a list that consists of hospitals and clinics and other providers that provide
prenatal care and abortions. None of the entries on the list are providers that principally
121
provide abortions. Although there are several appropriate licensed, qualified providers of
prenatal care in the area that do not provide or refer for abortions, none of these providers
are included on the list. Provision of the list is inconsistent with paragraphs (a) and (c) of
this section.
(5) A pregnant woman requests information on abortion and asks the Title X
project to refer her for an abortion. The project counselor tells her that the project does
not consider abortion a method of family planning and therefore does not refer for
abortion. The counselor further tells the client that the project can help her to obtain
prenatal care and necessary social services, and provides her with a list of such providers
from which the client may choose. Such actions are consistent with paragraph (a) of this
section.
(6) Title X project staff provide contraceptive counseling to a client in order to
assist her in selecting a contraceptive method. In discussing oral contraceptives, the
project counselor provides the client with information contained in the patient package
insert accompanying a brand of oral contraceptives, referring to abortion only in the
context of a discussion of the relative safety of various contraceptive methods and in no
way promoting abortion as a method of family planning. The provision of this
information does not constitute abortion referral.
§ 59.15 Maintenance of physical and financial separation.
A Title X project must be organized so that it is physically and financially
separate, as determined in accordance with the review established in this section, from
activities which are prohibited under section 1008 of the Act and §§ 59.13, 59.14, and
59.16 of these regulations from inclusion in the Title X program. In order to be physically
122
and financially separate, a Title X project must have an objective integrity and
independence from prohibited activities. Mere bookkeeping separation of Title X funds
from other monies is not sufficient. The Secretary will determine whether such objective
integrity and independence exist based on a review of facts and circumstances. Factors
relevant to this determination shall include:
(a) The existence of separate, accurate accounting records;
(b) The degree of separation from facilities (e.g., treatment, consultation,
examination and waiting rooms, office entrances and exits, shared phone numbers, email
addresses, educational services, and websites) in which prohibited activities occur and the
extent of such prohibited activities;
(c) The existence of separate personnel, electronic or paper-based health care
records, and workstations;
(d) The extent to which signs and other forms of identification of the Title X
project are present, and signs and material referencing or promoting abortion are absent.
§ 59.16 Prohibition on activities that encourage, promote or advocate for abortion.
(a) A Title X project may not encourage, promote or advocate abortion as a
method of family planning. This restriction prohibits actions to assist women to obtain
abortions or to increase the availability or accessibility of abortion for family planning
purposes. Prohibited actions include the use of Title X project funds for the following:
(1) Lobbying for the passage of legislation to increase in any way the availability
of abortion as a method of family planning;
(2) Providing speakers or educators who, in the Title X project or the use of Title
X project funds, promote the use of abortion as a method of family planning;
123
(3) Attending events or conferences during which the grantee or subrecipient
engages in lobbying;
(4) Paying dues to any group that, as a more than insignificant part of its
activities, advocates abortion as a method of family planning and does not separately
collect and segregate funds used for lobbying purposes;
(5) Using legal action to make abortion available in any way as a method of
family planning; and
(6) Developing or disseminating in any way materials (including printed matter,
audiovisual materials and web-based materials) advocating abortion as a method of
family planning or otherwise promoting a favorable attitude toward abortion.
(b) Examples.
(1) Clients at a Title X project are given brochures advertising a clinic that
provides abortions, or such brochures are available in any fashion at a Title X clinic
(sitting on a table or available or visible within the same space where Title X services are
provided). Provision or availability of the brochure violates paragraph (a)(6) of this
section.
(2) A Title X project makes an appointment for a pregnant client with an abortion
clinic. The Title X project has violated paragraph (a) of this section.
(3) A Title X project pays dues with project funds to a state association that,
among other activities, lobbies at state and local levels for the passage of legislation to
protect and expand the legal availability of abortion as a method of family planning. The
association spends a significant amount of its annual budget on such activity. Payment of
dues to the association violates paragraph (a)(4) of this section.
124
(4) An organization conducts a number of activities, including operating a Title X
project. The organization uses non-project funds to pay dues to an association that,
among other activities, engages in lobbying to protect and expand the legal availability of
abortion as a method of family planning. The association spends a significant amount of
its annual budget on such activity. Payment of dues to the association by the organization
does not violate paragraph (a)(4) of this section.
(5) An organization that operates a Title X project engages in lobbying to increase
the legal availability of abortion as a method of family planning. The project itself
engages in no such activities, and the facilities and funds of the project are kept separate
from prohibited activities. The project is not in violation of paragraph (a)(1) of this
section.
(6) Employees of a Title X project write their legislative representatives in
support of legislation seeking to expand the legal availability of abortion, in their
personal capacities and using no project funds to do so. The Title X project has not
violated paragraph (a)(1) of this section.
(7) On her own time and at her own expense, a Title X project employee speaks
before a legislative body in support of abortion as a method of family planning. The Title
X project has not violated paragraph (a) of this section.
(8) A Title X project uses Title X funds for sex education classes in a local high
school. During the course of the class, information is distributed to students that includes
abortion as a method of family planning. The Title X project has violated paragraph (a) of
this section.
§ 59.17 Compliance with reporting requirements.
125
(a) Title X projects shall comply with all State and local laws requiring
notification or reporting of child abuse, child molestation, sexual abuse, rape, incest,
intimate partner violence or human trafficking (collectively, “State notification laws”).
(b) A project may not receive funds under this subpart unless it provides
appropriate documentation or other assurance satisfactory to the Secretary that it:
(1) has in place and implemented a plan to comply with State laws Such plan shall
include, at a minimum, policies and procedures with respect to such notification and
reporting that include:
(i) a summary of obligations of the project or organizations and individuals
carrying out the project under State notification laws, including any obligation to inquire
or determine the age of a minor client or of a minor client’s sexual partner(s);
(ii) timely and adequate annual training of all individuals (whether or not they are
employees) serving clients for or on behalf of the project regarding State notification
laws; policies and procedures of the Title X project and/or provider with respect to
notification and reporting of child abuse, child molestation, sexual abuse, rape, incest,
intimate partner violence and human trafficking; and compliance with State notification
laws.
(iii) protocols to ensure that every minor who presents for treatment is provided
counseling on how to resist attempts to coerce them into engaging in sexual activities;
and
(iv) commitment to conduct a preliminary screening of any teen who presents
with a sexually transmitted disease (STD), pregnancy, or any suspicion of abuse, in order
to rule out victimization of a minor. Such screening would be required with respect to any
126
individual who is under the age of consent in the state of the proposed service area.
Projects are permitted to diagnose, test for, and treat STDs.
(2) maintains records to demonstrate compliance with each of the requirements
set forth in paragraph (b)(1) of this section, including which:
(i) indicate the age of minor clients;
(ii) indicate the age of the minor client’s sexual partners where required by law,
and
(iii) document each notification or report made pursuant to such State notification
laws.
(c) Continuation of grantee or subrecipient funding for Title X services is
contingent upon demonstrating to the satisfaction of the Secretary that the criteria have
been met.
(d) The Secretary may review records maintained by a grantee or subrecipient for
the sole purpose of ensuring compliance with the requirements of this section.
§ 59.18 Appropriate use of funds.
(a) Title X funds shall not be used to build infrastructure for purposes prohibited
with these funds, such as support for the abortion business of a Title X grantee or
subrecipient. Funds shall only be used for the purposes, and in direct implementation of
the funded project, expressly permitted with this regulation and authorized within section
1001 of the Public Health Service Act, that is, to offer family planning methods and
services. Grantees must use the majority of grant funds to provide direct services to
clients, and each grantee shall give a detailed accounting for the use of grant dollars, both
in their applications for funding, and within any annually required reporting. Further, any
127
significant change in the usage of grant funds within the grant cycle shall not be
undertaken without the approval of the Office of Population Affairs.
(b) Title X funds shall not be expended for any activity (including the publication
or distribution of literature) that in any way tends to promote public support or opposition
to any legislative proposal or candidate for office.
(c) Each project supported under Title X shall fully account for, and justify,
charges against the Title X grant. The Department shall put additional protections in
place to prevent any possible misuse of Title X funds through misbilling or overbilling,
or any other unallowable expense.
§ 59.19 Transition Provisions.
(a) In accordance with § 59.15, with respect to the requirement for physical
separation that becomes effective after [INSERT DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], covered entities must comply with the
applicable new requirements one year after the publication of the final rule.
(b) In accordance with § 59.15, with respect to the requirement for financial
separation that becomes effective after [INSERT DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], covered entities must comply with the
applicable new requirements no later than 60 days following publication of the final rule.
128
(c) In regards to all other requirements that become effective after [INSERT
DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER],
covered entities must comply no later than 60 days following publication of the final rule.
Dated: May 22, 2018.
—————————————————
Alex M. Azar II
Secretary
Department of Health and Human Services.
129

Title X Proposed Changes

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Notice: This HHS-approved document is being submitted to the Office of the Federal Register (OFR) for publication and

Billing Code: 5140-34-P

Department of Health and Human Services

[Docket No.: HHS-OS-2018-0008]

Compliance with Statutory Program Integrity Requirements

ACTION: Proposed rule.

planning and related statutory requirements. In addition, OPA proposes amendments to

provide a broad range of family planning methods; to require documented compliance

unable to obtain employer-sponsored insurance coverage for certain contraceptive

on lobbying or related activities; and to appropriately encourage family participation in

family planning decisions, all as required by Federal law.

be received by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE

ADDRESSES: Written comments may be submitted to the Department of Health and

most Internet search engines. No deletions, modifications, or redactions will be made to

the comments received. Comments may be submitted anonymously.

Comments, identified by “Family Planning” may be submitted by one of the following

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions

for submitting comments.

Washington, D.C. 20201.

Comments received will be posted without change to http://www.regulations.gov,

including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Valerie Huber at (202) 690-7694.

1001(a); 42 U.S.C. 300(a).

Presently, the Title X program funds approximately 90 public health departments

altered since it was enacted in 1970:

abortion is a method of family planning.

The Conference Report described the intent of this provision as follows:

legislation be used only to support preventive family planning services,

population research, infertility services and other related medical, information,

clear this intent.

annual appropriations provisos, reiterated this requirement: “[A]mounts provided to said

Stat. 135, 521 (2017).

(requirement to provide “a broad range of acceptable and effective family planning

requires that, “[n]otwithstanding any other provision of law, no provider of services

promulgate.” The Department began to exercise that authority by issuing regulations

as guidelines promulgated in 1981, prohibited Title X projects from providing abortion as

1. 1988 Regulations and Rust v. Sullivan

On February 2, 1988, the Secretary of Health and Human Services promulgated

effectively maintain the prohibition contained in section 1008.” Statutory Prohibition on

Use of Appropriated Funds in Programs Where Abortion is a Method of Family

statutory prohibition. To more effectively implement section 1008, the regulations

method of family planning; required grantees to separate their Title X project—

physically and financially—from any abortion activities; and implemented compliance

actions that promote or encourage, or advocate abortion as a method of family planning,

materials advocating abortion, or taking legal action to make abortion available as a

method of family planning. 53 FR 2922 (Feb. 2, 1988).

policies to the demands of changing circumstances.’” Id. (internal citations omitted).

requirements—the portions of the regulations mandating separate facilities, personnel,

program integrity requirements are necessary to implement the prohibition.” Id.

The Supreme Court similarly rejected constitutional challenges to the regulations.

that the statutory prohibition contained in § 1008 is constitutional” because Congress

provisions were consistent with the First Amendment as follows:

The challenged regulations implement the statutory prohibition by prohibiting

counseling, referral, and the provision of information regarding abortion as a

but of a prohibition on a project grantee or its employees from engaging in

activities outside of the project’s scope.

By requiring that the Title X grantee engage in abortion-related activity separately

teachings . . . not denied it the right to engage in abortion-related activities.

project in order to ensure the integrity of the federally funded program.

Amendment rights because the “Government has no constitutional duty to subsidize an

First or Fifth Amendments to the Constitution.” Id. at 203.

2. Suspension of 1988 Regulations and Finalization of 2000 Regulations

1993, when a new Administration suspended them pursuant to a Presidential

certain actions designed broadly to promote or encourage abortion as a method of family